The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Antimicrobial Alginate Dressing.
| Device ID | K024298 |
| 510k Number | K024298 |
| 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 Green |
| Correspondent | John Green 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 | No |
| Date Received | 2002-12-24 |
| Decision Date | 2003-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35032749039481 | K024298 | 000 |
| 15032749035298 | K024298 | 000 |
| 15032749035304 | K024298 | 000 |
| 15032749035311 | K024298 | 000 |
| 15051978002284 | K024298 | 000 |
| 15051978002314 | K024298 | 000 |
| 15051978002369 | K024298 | 000 |
| 35032749039450 | K024298 | 000 |
| 35032749039467 | K024298 | 000 |
| 35032749039474 | K024298 | 000 |
| 15032749035281 | K024298 | 000 |