The following data is part of a premarket notification filed by Keratec Limited with the FDA for Keratec Wound Dressings.
| Device ID | K080949 |
| 510k Number | K080949 |
| Device Name: | KERATEC WOUND DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | KERATEC LIMITED 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane KERATEC LIMITED 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-04-03 |
| Decision Date | 2009-02-11 |
| Summary: | summary |