The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Silicone Phmb Foam Wound Dressing.
| Device ID | K190819 |
| 510k Number | K190819 |
| Device Name: | Silicone PHMB Foam Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford, GB Cw7 3rt |
| Contact | Adam Gregory |
| Correspondent | Adam Gregory Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford, GB Cw7 3rt |
| 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 | 2019-04-01 |
| Decision Date | 2019-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610888002170 | K190819 | 000 |
| 10610888002163 | K190819 | 000 |
| 15032749025206 | K190819 | 000 |
| 15032749025190 | K190819 | 000 |
| 15032749025183 | K190819 | 000 |
| 15032749025176 | K190819 | 000 |
| 15032749025169 | K190819 | 000 |
| 15032749025152 | K190819 | 000 |
| 15032749025145 | K190819 | 000 |