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 |