The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Sis Hernia Graft.
| Device ID | K133306 |
| 510k Number | K133306 |
| Device Name: | SIS HERNIA GRAFT |
| Classification | Mesh, Surgical |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Perry W Guinn |
| Correspondent | Perry W Guinn COOK BIOTECH, INC. 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 | 2013-10-28 |
| Decision Date | 2014-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002552678 | K133306 | 000 |
| 00827002552661 | K133306 | 000 |
| 00827002552654 | K133306 | 000 |
| 00827002482166 | K133306 | 000 |
| 00827002466005 | K133306 | 000 |
| 00827002360334 | K133306 | 000 |
| 00827002360327 | K133306 | 000 |
| 00827002237643 | K133306 | 000 |
| 10827002239460 | K133306 | 000 |