The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Phmb Foam Wound Dressing.
| Device ID | K181197 |
| 510k Number | K181197 |
| Device Name: | 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 | 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 | 2018-05-07 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479243262 | K181197 | 000 |
| 20612479243259 | K181197 | 000 |
| 20612479243228 | K181197 | 000 |
| 15032749022717 | K181197 | 000 |
| 15032749021390 | K181197 | 000 |
| 15032749001323 | K181197 | 000 |
| 15032749001316 | K181197 | 000 |
| 15032749001293 | K181197 | 000 |
| 15032749001286 | K181197 | 000 |
| 15032749021383 | K181197 | 000 |
| 15032749021376 | K181197 | 000 |
| 15032749021369 | K181197 | 000 |
| 15032749021352 | K181197 | 000 |
| 15032749021345 | K181197 | 000 |
| 20612479243280 | K181197 | 000 |
| 20612479243310 | K181197 | 000 |
| 00612479243231 | K181197 | 000 |
| 00612479243415 | K181197 | 000 |
| 00612479243385 | K181197 | 000 |
| 00612479243354 | K181197 | 000 |
| 00612479243323 | K181197 | 000 |
| 00612479243293 | K181197 | 000 |
| 10610888000336 | K181197 | 000 |
| 10610888000329 | K181197 | 000 |
| 10610888000312 | K181197 | 000 |
| 10610888000305 | K181197 | 000 |
| 20612479243402 | K181197 | 000 |
| 20612479243372 | K181197 | 000 |
| 20612479243341 | K181197 | 000 |
| 15032749001637 | K181197 | 000 |