The following data is part of a premarket notification filed by Convatec Limited with the FDA for Aquacel Ag+ Extra Enhanced Hydrofiber Dressing With Silver And Strengthening Fiber.
| Device ID | K173675 |
| 510k Number | K173675 |
| Device Name: | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing With Silver And Strengthening Fiber |
| Classification | Dressing, Wound, Drug |
| Applicant | ConvaTec Limited First Avenue, Deeside Industrial Park Deeside, GB Ch5 2nu |
| Contact | Justin Lovelace |
| Correspondent | Justin Lovelace ConvaTec Limited First Avenue, Deeside Industrial Park Deeside, GB Ch5 2nu |
| 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 | 2017-11-30 |
| Decision Date | 2018-07-20 |
| Summary: | summary |