The following data is part of a premarket notification filed by Apr Applied Pharma Research Sa with the FDA for Nexodyn Aos Wound Care Solution.
| Device ID | K151168 |
| 510k Number | K151168 |
| Device Name: | Nexodyn AOS Wound Care Solution |
| Classification | Dressing, Wound, Drug |
| Applicant | APR Applied Pharma Research SA Via Corti 5 Balerna, CH 6828 |
| Contact | Giorgio Reiner |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING Srl PIAZZA ALBANIA 10 Rome, IT 00153 |
| 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 | 2015-05-01 |
| Decision Date | 2015-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640158091678 | K151168 | 000 |