The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Diaphragmatic Hernia Graft.
| Device ID | K133011 |
| 510k Number | K133011 |
| Device Name: | DIAPHRAGMATIC HERNIA GRAFT |
| Classification | Mesh, Surgical, Collagen, Diaphragmatic Hernia |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Mary A Faderan Ph.d., Rac |
| Correspondent | Mary A Faderan Ph.d., Rac COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | OWV |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002515789 | K133011 | 000 |
| 00827002314559 | K133011 | 000 |
| 10827002565804 | K133011 | 000 |