The following data is part of a premarket notification filed by Cook Biotech Incorprated with the FDA for Biodesign Otologic Repair Graft.
| Device ID | K150594 |
| 510k Number | K150594 |
| Device Name: | Biodesign Otologic Repair Graft |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Katie Molland COOK BIOTECH INCORPRATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002448407 | K150594 | 000 |
| 00827002448391 | K150594 | 000 |
| 00827002444522 | K150594 | 000 |
| 00827002444515 | K150594 | 000 |