The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Biodesign Enterocutaneous Fistula Plug.
| Device ID | K082682 |
| 510k Number | K082682 |
| Device Name: | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1 Geddes Way West Lafayette, IN 47906 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon COOK BIOTECH, INC. 1 Geddes Way West Lafayette, IN 47906 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2009-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002236547 | K082682 | 000 |
| 00827002236530 | K082682 | 000 |