The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Modification To Silver Alginate Ii Wound Dressing.
| Device ID | K063173 |
| 510k Number | K063173 |
| Device Name: | MODIFICATION TO SILVER ALGINATE II WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ADVANCED MEDICAL SOLUTIONS LIMITED ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Contact | Grahame Somerville |
| Correspondent | Grahame Somerville 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 | 2006-10-19 |
| Decision Date | 2006-11-03 |
| Summary: | summary |