FDA 510(k) Applications Submitted by COOK BIOTECH, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070405 |
02/12/2007 |
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
| K062729 |
09/13/2006 |
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG |
COOK BIOTECH, INC. |
| K082682 |
09/15/2008 |
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG |
COOK BIOTECH, INC. |
| K082058 |
07/21/2008 |
DYNAMATRIX |
COOK BIOTECH, INC. |
| K050246 |
02/02/2005 |
SIS DERMAL AUGMENTATION STRAND |
COOK BIOTECH, INC. |
| K050337 |
02/10/2005 |
SIS FISTULA PLUG |
COOK BIOTECH, INC. |
| K020654 |
02/28/2002 |
STRATASIS SLING KIT |
COOK BIOTECH, INC. |
| K020732 |
03/06/2002 |
SS MATRIX |
COOK BIOTECH, INC. |
| K010952 |
03/30/2001 |
SURGISIS GUIDED TISSUE REGENERATION MATRIX |
COOK BIOTECH, INC. |
| K031069 |
04/04/2003 |
SURGISIS NERVE CUFF |
COOK BIOTECH, INC. |
| K051048 |
04/25/2005 |
SURGISIS STAPLE LINE REINFORCEMENT II |
COOK BIOTECH, INC. |
| K031850 |
06/16/2003 |
DURASIS DURAL SUBSTITUTE |
COOK BIOTECH, INC. |
| K022044 |
06/24/2002 |
SURGISIS STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
| K034039 |
12/29/2003 |
SIS PLASTIC SURGERY MATRIX |
COOK BIOTECH, INC. |
| K070738 |
03/16/2007 |
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT |
COOK BIOTECH, INC. |
| K090688 |
03/16/2009 |
COOK UROLOGICAL GRAFT |
COOK BIOTECH, INC. |
| K131015 |
04/11/2013 |
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT |
COOK BIOTECH, INC. |
| K062320 |
08/09/2006 |
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 |
COOK BIOTECH, INC. |
| K062696 |
09/11/2006 |
SURGISIS, SURGISIS ES |
COOK BIOTECH, INC. |
| K062697 |
09/11/2006 |
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT |
COOK BIOTECH, INC. |
| K073391 |
12/03/2007 |
SURGISIS BIODESIGN TISSUE GRAFT |
COOK BIOTECH, INC. |
| K133011 |
09/25/2013 |
DIAPHRAGMATIC HERNIA GRAFT |
COOK BIOTECH, INC. |
| K111695 |
06/16/2011 |
HYBRID GRAFT |
COOK BIOTECH, INC. |
| K001785 |
06/13/2000 |
SURGISIS PERIPHERAL VASCULAR PATCH |
COOK BIOTECH, INC. |
| K992159 |
06/25/1999 |
SURGISIS SLING |
COOK BIOTECH, INC. |
| K973170 |
08/25/1997 |
SIS WOUND DRESSING |
COOK BIOTECH, INC. |
| K993948 |
11/22/1999 |
SIS WOUND DRESSING II |
COOK BIOTECH, INC. |
| K980431 |
02/04/1998 |
SURGISIS |
COOK BIOTECH, INC. |
| K110402 |
02/11/2011 |
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER |
COOK BIOTECH, INC. |
| K061711 |
06/19/2006 |
OASIS WOUND MATRIX |
COOK BIOTECH, INC. |
| K133306 |
10/28/2013 |
SIS HERNIA GRAFT |
COOK BIOTECH, INC. |
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