The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Surgical Silver Post Operative Dressing.
| Device ID | K180634 |
| 510k Number | K180634 |
| Device Name: | Surgical Silver Post Operative Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford, GB Cw7 3rt |
| Contact | Rose Guang |
| Correspondent | Rose Guang 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 | 2018-03-12 |
| Decision Date | 2018-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888277717138 | K180634 | 000 |
| 15032749025022 | K180634 | 000 |
| 15032749025039 | K180634 | 000 |
| 15032749025046 | K180634 | 000 |
| 15032749025053 | K180634 | 000 |
| 15032749025060 | K180634 | 000 |
| 15032749027439 | K180634 | 000 |
| 10193489020182 | K180634 | 000 |
| 10888277717091 | K180634 | 000 |
| 10888277717107 | K180634 | 000 |
| 10888277717114 | K180634 | 000 |
| 10888277717121 | K180634 | 000 |
| 15032749025015 | K180634 | 000 |