The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Parastomal Hernia Repair Graft.
| Device ID | K162934 |
| 510k Number | K162934 |
| Device Name: | Biodesign Parastomal Hernia Repair Graft |
| Classification | Mesh, Surgical |
| Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Daniela I. Changkuon Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Product Code | FTM |
| Subsequent Product Code | FTL |
| Subsequent Product Code | OXK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-20 |
| Decision Date | 2017-07-10 |
| Summary: | summary |