The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug.
| Device ID | K161221 |
| 510k Number | K161221 |
| Device Name: | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug |
| Classification | Mesh, Surgical |
| Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Perry W. Guinn Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002352476 | K161221 | 000 |