The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft.
| Device ID | K191696 |
| 510k Number | K191696 |
| Device Name: | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft |
| Classification | Mesh, Surgical, Collagen, Fistula |
| Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Nick Wang Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Product Code | OXN |
| Subsequent Product Code | FTM |
| Subsequent Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2019-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002583310 | K191696 | 000 |
| 10827002590592 | K191696 | 000 |
| 00827002590663 | K191696 | 000 |
| 00827002590656 | K191696 | 000 |
| 00827002590649 | K191696 | 000 |
| 00827002590632 | K191696 | 000 |
| 00827002590625 | K191696 | 000 |
| 00827002590618 | K191696 | 000 |
| 00827002590601 | K191696 | 000 |
| 10827002590608 | K191696 | 000 |
| 10827002590615 | K191696 | 000 |
| 10827002590622 | K191696 | 000 |
| 10827002583303 | K191696 | 000 |
| 10827002583297 | K191696 | 000 |
| 10827002583280 | K191696 | 000 |
| 10827002583273 | K191696 | 000 |
| 10827002590660 | K191696 | 000 |
| 10827002590653 | K191696 | 000 |
| 10827002590646 | K191696 | 000 |
| 10827002590639 | K191696 | 000 |
| 00827002590595 | K191696 | 000 |