The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Flowable Wound Matrix.
| Device ID | K160136 |
| 510k Number | K160136 |
| Device Name: | Flowable Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Perry W. Guinn |
| Correspondent | Nick Wang COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002584218 | K160136 | 000 |
| 00827002590915 | K160136 | 000 |
| 00827002590748 | K160136 | 000 |