FDA 510(k) Applications for Medical Device Product Code "BSJ"
(Mask, Gas, Anesthetic)

FDA 510(k) Number Applicant Device Name Decision Date
K950771 ADVANCED WARMING SYSTEMS, INC. DISPOSABLE ADHESIVE FACE MASK 03/10/1995
K932014 AMBU, INC. AMBU DISPOSABLE FACE MASK 06/22/1993
K854161 ANESTHESIA RESPIRATORY TECHNOLOGY, INC. SUR-FIT FACE MASK 11/05/1985
K803185 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NON-CONDUCTIVE ANESTHESIA FACE MASK 01/05/1981
K872015 BRIGAM, INC. SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) 06/17/1987
K782163 COLLECTOVAC, INC. THE BLUE MASK 03/01/1979
K891316 CONCORD/PORTEX ANESTHESIA/RESPIRATORY DISPOSABLE MASK 08/21/1989
K842472 DRYDEN CORP. DRYDEN INFLATABLE MASK 07/06/1984
K882434 EASTMED ENTERPRISES INC. MASK, GAS, ANESTHETIC 06/30/1988
K871851 ENGINEERED MEDICAL SYSTEMS RIBBED CUSHION MASK 06/08/1987
K874746 ENGINEERED MEDICAL SYSTEMS SEALFLEX MASK 12/21/1987
K945440 FVTNKS DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK 11/08/1994
K945894 HANS RUDOLPH, INC. MASK, GAS, ANESTHETIC 01/27/1995
K932147 HANS RUDOLPH, INC. NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE 08/20/1993
K841240 HOSPITAK, INC. DISPOSABLE ANESTHESIA MASK 04/05/1984
K915558 IAS IAS ANESTHESIA MASK 04/08/1992
K880682 KING SYSTEMS CORP. MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP 03/21/1988
K884387 LIFE DESIGN SYSTEMS, INC. CUSHION FLEX(TM) 11/17/1988
K843169 LIFE DESIGN SYSTEMS, INC. CUSHION-FLEX TM 08/20/1984
K890108 LIFE DESIGN SYSTEMS, INC. MODIFIED CUSHION-FLEX(TM) 01/24/1989
K860686 LORAN LTD. FACEGLOV,ANESTHETIC GAS MASK 04/30/1986
K953295 MALLINCKRODT MEDICAL ANESTHESIA FACE MASK 08/11/1995
K840535 MARQUEST MEDICAL PRODUCTS, INC. DISPOS. ANESTHESIA FACE MASK 02/21/1984
K853785 MED SYSTEMS SERIES 2000 MEDS MASK 12/03/1985
K881067 MEDESIGN, INC. NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK 03/24/1988
K953107 MEDICAL MARKETING CONCEPTS ANESTHESIA/RESPIRATORY FACE MASK 08/15/1995
K844493 MEDIPART JERRY ALEXANDER MEDIPART FACE MASK & FILTER MP-30XM 12/04/1984
K844494 MEDIPART JERRY ALEXANDER MEDIPART FACE MASK MP-XM 12/04/1984
K862782 MEDIPART JERRY ALEXANDER MP-XML DISPOSABLE FACE MASK 08/01/1986
K862781 MEDIPART JERRY ALEXANDER MP-XMM DISPOSABLE FACE MASK 08/01/1986
K862784 MEDIPART JERRY ALEXANDER MP-XMO DISPOSABLE FACE MASK 08/01/1986
K862783 MEDIPART JERRY ALEXANDER MP-XMV DISPOSABLE FACE MASK 08/01/1986
K830982 MEDOVATIONS, INC. MASKS 05/09/1983
K944157 MERIDIAN MEDICAL SYSTEMS, INC. DISPOSABLE, PREFORMED FACE MASK 10/03/1994
K810990 OHIO MEDICAL PRODUCTS OHIO NONCONDUCTIVE RBS TYPE FACE MASK 04/23/1981
K840452 OHIO MEDICAL PRODUCTS PREMIUM DABM DISPOS. ANES. BREATH MASK 02/17/1984
K952689 OWENS-BRIGAM MEDICAL CO. BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK 07/11/1995
K790638 PARKER LABORATORIES, INC. ACCUTRON POLLUTION REDUCER 05/25/1979
K850263 PLASMEDICS, INC. PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY 03/25/1985
K951043 PROMEDIC, INC. AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK 06/07/1995
K890795 RESPIRONICS, INC. RESPIRONICS SEALEASY II 04/20/1989
K902298 RONDEX PRODUCTS, INC. ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS 08/22/1990
K881393 RONDEX PRODUCTS, INC. RONDEX RESCUE MASK 04/25/1988
K903881 VENTLAB CORP. VENTLAB VENT-MASK, CAT# VR 0010/20/30 09/04/1990
K831713 VITAL SIGNS, INC. NON CONDUCTIVE ANESTHESIA FACEMASK 07/07/1983
K821045 VITAL SIGNS, INC. NON CONDUCTIVE PEDIATRIC ANES. FACE 04/26/1982
K801251 VITAL SIGNS, INC. NON-CONDUCTIVE, SINGLE USE FACE MASK #55 06/04/1980
K884157 WALT'S PRODUCTS MODIFIED TOUCH-ME-NOT MASK 08/21/1989
K834536 WARNE SURGICAL PRODUCTS, LTD. CRYSTALCONE FACE MASK-MED-W/HOOKRING 01/25/1984
K834454 WARNE SURGICAL PRODUCTS, LTD. PAEDIATRIC FACE MASK 1-3 W/WO RING 01/18/1984


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