FDA 510(k) Applications for Medical Device Product Code "BTC"
(Bag, Reservoir)

FDA 510(k) Number Applicant Device Name Decision Date
K830056 ARTEC ENVIRONMENTAL MONITORING DIVISION ARTEC TWIST VALVE 03/09/1983
K791463 CAMERON MEDICAL CORP. "PARA-VENT" 09/17/1979
K800155 DRYDEN CORP. DISPOSAL LITER BREATHING BAG 02/21/1980
K821309 ESP PLASTICS, INC. ESPREE', BREATHING BAG 05/21/1982
K830399 KHI, INC. COUPLING/VALVE 03/10/1983
K880680 KING SYSTEMS CORP. KING SYSTEMS, BREATHING BAG 03/03/1988
K822116 LIFE DESIGN SYSTEMS, INC. ANESTHESIA BREATHING BAG, VARIOUS SIZES 08/16/1982
K932191 LIFE SHIELD HEALTHCARE PRODUCTS, INC. BREATHING BAGS 07/02/1993
K932581 MED-PLASTICS INTL., INC. BREATHING BAGS 07/16/1993
K894906 MED-TEK CORP. ANESTHESIA BREATHING BAGS "SIZES 1/2, 1,2,3 LITER" 09/18/1989
K791910 MEM MEDICAL, INC. THREE LITER BAG #M-512 10/09/1979
K932584 MERIT MEDICAL SYSTEMS, INC. BREATHING BAGS 07/16/1993
K932496 PRECISION MED PRODUCTS, LTD. PRECISION MED PRODUCTS, LTD. BREATHING BAGS 07/16/1993
K822216 QUEST MEDICAL, INC. VOLUMETRIC CONTROLLER 08/16/1982
K864822 SURGIDYNE, INC. VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS 01/15/1987
K841411 WARNE SURGICAL PRODUCTS, LTD. ROLLED NECK W/PLUG 04/18/1984
K841412 WARNE SURGICAL PRODUCTS, LTD. ROLLED NECK W/TAP 04/18/1984
K940220 ZEFON MEDICAL PRODUCTS REBREATHER BAGS 05/27/1994


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