The following data is part of a premarket notification filed by Keranetics with the FDA for Kerastat Cream.
| Device ID | K192386 |
| 510k Number | K192386 |
| Device Name: | KeraStat Cream |
| Classification | Dressing, Wound, Collagen |
| Applicant | KeraNetics 200 East First Street, Suite 101, Box#4 Winston Salem, NC 27101 |
| Contact | Luke Burnett |
| Correspondent | Luke Burnett KeraNetics 200 East First Street, Suite 101, Box#4 Winston Salem, NC 27101 |
| 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 | 2019-09-03 |
| Decision Date | 2020-07-16 |