The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Non-adherent Antimicrobial Alginate Dressing, Silvercel Non-adherent Antimicrobial Alginate Dressing.
| Device ID | K081363 |
| 510k Number | K081363 |
| Device Name: | NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ADVANCED MEDICAL SOLUTIONS LIMITED ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford Cheshire, GB Cw7 3pd |
| Contact | Claire Ryan |
| Correspondent | Claire Ryan ADVANCED MEDICAL SOLUTIONS LIMITED ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford Cheshire, GB Cw7 3pd |
| 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 | 2008-05-15 |
| Decision Date | 2008-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051978002499 | K081363 | 000 |
| 15051978002482 | K081363 | 000 |
| 15051978002475 | K081363 | 000 |
| 15051978002468 | K081363 | 000 |
| 15051978002390 | K081363 | 000 |
| 35032749039443 | K081363 | 000 |
| 35032749039436 | K081363 | 000 |
| 35032749039429 | K081363 | 000 |
| 35032749039412 | K081363 | 000 |