The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Staple Line Reinforcement Ii.
| Device ID | K051048 |
| 510k Number | K051048 |
| Device Name: | SURGISIS STAPLE LINE REINFORCEMENT II |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Mark Bleyer |
| Correspondent | Mark Bleyer COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-09-23 |
| Summary: | summary |