The following data is part of a premarket notification filed by Keranetics, Llc. with the FDA for Kerastat(r) Gel.
| Device ID | K162759 |
| 510k Number | K162759 |
| Device Name: | KeraStat(R) Gel |
| Classification | Dressing, Wound, Collagen |
| Applicant | KeraNetics, LLC. 200 East First Stree, Box #4, Suite 102 Winston-salem, NC 27101 |
| Contact | Luke Burnett |
| Correspondent | Kenneth G. Butz PPD, LLC. 3900 PARAMOUNT PARKWAY Morrisville, NC 27560 -7200 |
| 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 | 2016-09-30 |
| Decision Date | 2017-06-02 |
| Summary: | summary |