The following data is part of a premarket notification filed by Stratus Pharmaceutical with the FDA for Sonafine Wound Dressing.
| Device ID | K110172 |
| 510k Number | K110172 |
| Device Name: | SONAFINE WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | STRATUS PHARMACEUTICAL 12379 SW 130TH STREET Miami, FL 33186 |
| Contact | Alberto Hoyo |
| Correspondent | Alberto Hoyo STRATUS PHARMACEUTICAL 12379 SW 130TH STREET Miami, FL 33186 |
| 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 | 2011-01-20 |
| Decision Date | 2011-08-19 |
| Summary: | summary |