The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Acticoat Surgical Dressing.
| Device ID | K153723 |
| 510k Number | K153723 |
| Device Name: | ACTICOAT Surgical Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Samantha Neilson |
| Correspondent | Samantha Neilson Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| 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 | 2015-12-28 |
| Decision Date | 2016-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223468187 | K153723 | 000 |
| 05000223459369 | K153723 | 000 |
| 05000223459345 | K153723 | 000 |
| 05000223459321 | K153723 | 000 |