The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Silver Antimicrobial Wound Gel.
| Device ID | K110458 |
| 510k Number | K110458 |
| Device Name: | SILVER ANTIMICROBIAL WOUND GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | ADVANCED MEDICAL SOLUTIONS LIMITED PREMIER PARK, 33 ROAD ONE, WINSFORD INDUSTRIAL ESTATE Winsford Cheshire, GB Cw7 3pd |
| Contact | Claire Ryan |
| Correspondent | Claire Ryan ADVANCED MEDICAL SOLUTIONS LIMITED PREMIER PARK, 33 ROAD ONE, WINSFORD INDUSTRIAL ESTATE Winsford Cheshire, GB Cw7 3pd |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-02-17 |
| Decision Date | 2011-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610888002071 | K110458 | 000 |
| 07332551950200 | K110458 | 000 |
| 05032749040127 | K110458 | 000 |
| 20612479269181 | K110458 | 000 |