The following data is part of a premarket notification filed by Advanced Medical Solutions Group Plc with the FDA for Spyrogel Hydrogel Wound And Burn Dressing Sa.
| Device ID | K991287 |
| 510k Number | K991287 |
| Device Name: | SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Contact | Christopher Oakes |
| Correspondent | Christopher Oakes ADVANCED MEDICAL SOLUTIONS GROUP PLC ROAD THREE, WINFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-14 |
| Decision Date | 1999-06-29 |
| Summary: | summary |