The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Silver Alginate Ii Wound Dressing.
| Device ID | K070581 |
| 510k Number | K070581 |
| Device Name: | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-03-01 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884389811287 | K070581 | 000 |
| 40080196323174 | K070581 | 000 |
| 10884389124055 | K070581 | 000 |
| 10080196297122 | K070581 | 000 |
| 10080196297115 | K070581 | 000 |
| 10080196297108 | K070581 | 000 |
| 10080196297092 | K070581 | 000 |