The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Oasis Wound Matrix.
| Device ID | K061711 |
| 510k Number | K061711 |
| Device Name: | OASIS WOUND MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Contact | Perry W Guinn |
| Correspondent | Perry W Guinn COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906 -1000 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-19 |
| Decision Date | 2006-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002466279 | K061711 | 000 |
| 10827002564630 | K061711 | 000 |
| 10827002466262 | K061711 | 000 |
| 10827002466224 | K061711 | 000 |
| 10827002352459 | K061711 | 000 |
| 10827002352442 | K061711 | 000 |
| 10827002352435 | K061711 | 000 |
| 10827002352428 | K061711 | 000 |
| 00827002231207 | K061711 | 000 |
| 10827002231198 | K061711 | 000 |
| 10827002590929 | K061711 | 000 |
| 10827002466460 | K061711 | 000 |
| 00827002590922 | K061711 | 000 |
| 00827002564640 | K061711 | 000 |
| 10827002564654 | K061711 | 000 |
| 10827002466231 | K061711 | 000 |
| 00827002576100 | K061711 | 000 |
| 00827002576094 | K061711 | 000 |
| 00827002576087 | K061711 | 000 |
| 10827002576077 | K061711 | 000 |
| 10827002576060 | K061711 | 000 |
| 10827002576053 | K061711 | 000 |
| 10827002576046 | K061711 | 000 |
| 10827002576039 | K061711 | 000 |
| 10827002576022 | K061711 | 000 |
| 10827002576015 | K061711 | 000 |
| 00827002564664 | K061711 | 000 |
| 00827002466463 | K061711 | 000 |