FDA 510(k) Applications Submitted by MARY P LEGRAW

FDA 510(k) Number Submission Date Device Name Applicant
K072520 09/07/2007 TEPHAFLEX SURGICAL FILM TEPHA, INC.
K950352 01/30/1995 PRECEDER GUIDEWIRE BOSTON SCIENTIFIC CORP.
K960501 02/02/1996 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K970379 02/03/1997 CHANNEL BALLOON CATHETER BOSTON SCIENTIFIC CORP.
K130326 02/08/2013 TEPHAFLEX MELTBLOWN CONSTRUCT TEPHA, INC.
K010633 03/02/2001 RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM MITEK PRODUCTS
K140533 03/04/2014 GALAFLEX MESH TEPHA, INC.
K000936 03/23/2000 VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS
K070894 03/30/2007 TEPHAFLEX SURGICAL MESH TEPHA, INC.
K971254 04/03/1997 TRANSEND EX PLATINUM GUIDEWIRE BOSTON SCIENTIFIC CORP.
K081099 04/17/2008 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC.
K101287 05/07/2010 TEPHAFLEX COMPOSITE MESH TEPHA, INC.
K952656 05/08/1995 XXL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
DEN060003 05/12/2006 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC.
K091633 06/04/2009 TEPHAFLEX SURGICAL FILM TEPHA, INC.
K972357 06/25/1997 BLUE MAX - 20 BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K953023 06/29/1995 PRECEDER GUIDEWIRE BOSTON SCIENTIFIC CORP.
K953114 07/03/1995 EVOLUTION MICROCATHETER BOSTON SCIENTIFIC CORP.
K111946 07/08/2011 TEPHAFLEX MESH TEPHA, INC.
K972744 07/23/1997 COURIER ST BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K132348 07/29/2013 TEPHAFLEX BRAIDED SUTURE TEPHA, INC.
K953569 07/31/1995 COURIER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K082178 08/01/2008 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC.
K953602 08/02/1995 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K002422 08/08/2000 VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS
K973008 08/13/1997 COURIER ST BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K052225 08/16/2005 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC.
K002639 08/24/2000 BIOKNOTLESS ANCHOR MITEK PRODUCTS
K963397 08/29/1996 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K963691 09/16/1996 COURIER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.
K963988 10/04/1996 INTRAVASCULAR INFUSION DEVICE BOSTON SCIENTIFIC CORP.
K944959 10/07/1994 AMPLATZ SUPER STIFF GUIDEWIRE BOSTON SCIENTIFIC CORP.
K945379 11/02/1994 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING BOSTON SCIENTIFIC CORP.
K945666 11/17/1994 EVOLUTION(TM) MICROCATHETER BOSTON SCIENTIFIC CORP.
K964611 11/18/1996 TRANSEND GUIDEWIRE BOSTON SCIENTIFIC CORP.
K113721 12/19/2011 TEPHAFLEX LIGHT MESH TEPHA, INC.
K113723 12/19/2011 TEPHAFLEX MESH TEPHA, INC.


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