The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Durafiber Ag.
| Device ID | K161289 |
| 510k Number | K161289 |
| Device Name: | DURAFIBER Ag |
| Classification | Dressing, Wound, Drug |
| Applicant | SMITH & NEPHEW MEDICAL LIMITED 101 HESSLE RD Hull, GB Hu3 2bn |
| Contact | Samantha Neilson |
| Correspondent | Amy Campbell SMITH & NEPHEW, INC. 3909 HULEN ST Fort Worth, TX 76107 |
| 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 | 2016-05-09 |
| Decision Date | 2016-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223467999 | K161289 | 000 |
| 05000223480226 | K161289 | 000 |
| 05000223467906 | K161289 | 000 |
| 05000223467968 | K161289 | 000 |
| 05000223467937 | K161289 | 000 |
| 05000223467876 | K161289 | 000 |