The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Allevyn Ag Dressing.
| Device ID | K063835 |
| 510k Number | K063835 |
| Device Name: | ALLEVYN AG DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
| Contact | Terry Mcmahon |
| Correspondent | Terry Mcmahon SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
| 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 | 2006-12-26 |
| Decision Date | 2007-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223459789 | K063835 | 000 |
| 05000223459901 | K063835 | 000 |
| 05000223459932 | K063835 | 000 |
| 05000223459963 | K063835 | 000 |
| 05000223459994 | K063835 | 000 |
| 05000223460020 | K063835 | 000 |
| 05000223461935 | K063835 | 000 |
| 05000223466022 | K063835 | 000 |
| 05000223465872 | K063835 | 000 |
| 05000223465933 | K063835 | 000 |
| 05000223465995 | K063835 | 000 |
| 05000223466053 | K063835 | 000 |
| 05000223459840 | K063835 | 000 |