The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Diaphragmatic Hernia Graft.
| Device ID | K171817 |
| 510k Number | K171817 |
| Device Name: | Biodesign Diaphragmatic Hernia Graft |
| Classification | Mesh, Surgical |
| Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Nick X. Wang Cook Biotech Incorporated 1425 Innovation Place 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 | 2017-06-19 |
| Decision Date | 2018-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002592879 | K171817 | 000 |
| 10827002515793 | K171817 | 000 |