The following data is part of a premarket notification filed by Advanced Medical Solutions Group Plc with the FDA for Advanced Medical Solutions-silicone Gel Scar Management Sheet.
| Device ID | K991630 |
| 510k Number | K991630 |
| Device Name: | ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Contact | Chris Oakes |
| Correspondent | Chris Oakes ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD 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 | 1999-05-11 |
| Decision Date | 1999-06-11 |
| Summary: | summary |