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 |