The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Silver Alginate Iv Antimicrobial Wound Dressing.
| Device ID | K080503 |
| 510k Number | K080503 |
| Device Name: | SILVER ALGINATE IV ANTIMICROBIAL 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-02-25 |
| Decision Date | 2008-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610888000169 | K080503 | 000 |
| 10610888000152 | K080503 | 000 |
| 10610888000145 | K080503 | 000 |
| 15032749025473 | K080503 | 000 |
| 15032749023288 | K080503 | 000 |
| 15032749023271 | K080503 | 000 |
| 15032749023264 | K080503 | 000 |
| 15032749023240 | K080503 | 000 |
| 15032749023233 | K080503 | 000 |