The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Silver High Performance Dressing.
| Device ID | K183645 |
| 510k Number | K183645 |
| Device Name: | Silver High Performance Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Advanced Medical Solutions Ltd. Premier Park, 33 , Winsford Industrial Estate Winsford, GB Cw7 3rt |
| Contact | Amy Turner |
| Correspondent | Amy Turner Advanced Medical Solutions Ltd. Premier Park, 33 , 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 | 2018-12-26 |
| Decision Date | 2019-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15032749025503 | K183645 | 000 |
| 20612479253029 | K183645 | 000 |
| 10610888002156 | K183645 | 000 |
| 10610888002149 | K183645 | 000 |
| 10610888002132 | K183645 | 000 |
| 00612479253148 | K183645 | 000 |
| 00612479253117 | K183645 | 000 |
| 00612479253087 | K183645 | 000 |
| 00612479253056 | K183645 | 000 |
| 20612479253050 | K183645 | 000 |
| 20612479253081 | K183645 | 000 |
| 15032749025121 | K183645 | 000 |
| 15032749025114 | K183645 | 000 |
| 15032749025107 | K183645 | 000 |
| 15032749025091 | K183645 | 000 |
| 15032749025084 | K183645 | 000 |
| 15032749025077 | K183645 | 000 |
| 20612479253142 | K183645 | 000 |
| 20612479253111 | K183645 | 000 |
| 00612479253025 | K183645 | 000 |