The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Hybrid Graft.
| Device ID | K111695 |
| 510k Number | K111695 |
| Device Name: | HYBRID GRAFT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Mary A Faderan, Phd, Rac |
| Correspondent | Mary A Faderan, Phd, Rac COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-16 |
| Decision Date | 2012-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002354798 | K111695 | 000 |
| 10827002354774 | K111695 | 000 |
| 10827002354767 | K111695 | 000 |
| 10827002351148 | K111695 | 000 |
| 10827002237725 | K111695 | 000 |
| 10827002237718 | K111695 | 000 |
| 10827002237701 | K111695 | 000 |