The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Sis Wound Dressing.
| Device ID | K973170 |
| 510k Number | K973170 |
| Device Name: | SIS WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | COOK BIOTECH, INC. P.O. BOX 2603, 3055 KENT AVE. West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot COOK BIOTECH, INC. P.O. BOX 2603, 3055 KENT AVE. 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 | 1997-08-25 |
| Decision Date | 1998-04-30 |
| Summary: | summary |