The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acticoat Flex 7 Dressing.
| Device ID | K083113 |
| 510k Number | K083113 |
| Device Name: | ACTICOAT FLEX 7 DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716 |
| Contact | Terry Mcmahon |
| Correspondent | Terry Mcmahon SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716 |
| 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 | 2008-10-21 |
| Decision Date | 2009-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565125282 | K083113 | 000 |
| 00040565124940 | K083113 | 000 |
| 00040565124988 | K083113 | 000 |
| 00040565124469 | K083113 | 000 |
| 00040565124520 | K083113 | 000 |
| 00040565124544 | K083113 | 000 |
| 00040565124506 | K083113 | 000 |
| 00040565125008 | K083113 | 000 |
| 00040565125022 | K083113 | 000 |
| 00040565125046 | K083113 | 000 |
| 00040565125060 | K083113 | 000 |
| 00040565124483 | K083113 | 000 |