The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Activheal Scar Management Dressing.
| Device ID | K010245 |
| 510k Number | K010245 |
| Device Name: | ACTIVHEAL SCAR MANAGEMENT DRESSING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ADVANCED MEDICAL SOLUTIONS LTD. ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Contact | Chris Oakes |
| Correspondent | Chris Oakes ADVANCED MEDICAL SOLUTIONS LTD. ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-25 |
| Decision Date | 2001-04-25 |