The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Sis Fistula Plug.
| Device ID | K050337 |
| 510k Number | K050337 |
| Device Name: | SIS FISTULA PLUG |
| 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 | 2005-02-10 |
| Decision Date | 2005-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002536142 | K050337 | 000 |
| 10827002362267 | K050337 | 000 |