The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Phmb Antimicrobial Foam Wound Dressing.
| Device ID | K163062 |
| 510k Number | K163062 |
| Device Name: | PHMB Antimicrobial 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 | Kay Mcgrath |
| Correspondent | Kay Mcgrath 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 | 2016-11-02 |
| Decision Date | 2017-07-25 |
| Summary: | summary |