The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acticoat Moisture Control Dressing.
| Device ID | K050030 |
| 510k Number | K050030 |
| Device Name: | ACTICOAT MOISTURE CONTROL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C 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 | 2005-01-07 |
| Decision Date | 2005-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223468545 | K050030 | 000 |