The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Silver Alginate 11 Wound Dressing.
| Device ID | K090453 |
| 510k Number | K090453 |
| Device Name: | SILVER ALGINATE 11 WOUND 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-23 |
| Decision Date | 2009-02-26 |
| Summary: | summary |
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|---|---|---|
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