The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Antimicrobial Alginate Dressing.
| Device ID | K041316 |
| 510k Number | K041316 |
| Device Name: | ANTIMICROBIAL ALGINATE DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ADVANCED MEDICAL SOLUTIONS LTD. ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Contact | John E Greenham |
| Correspondent | John E Greenham ADVANCED MEDICAL SOLUTIONS LTD. 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 | 2004-05-17 |
| Decision Date | 2004-08-05 |
| Summary: | summary |