The following data is part of a premarket notification filed by Quinnova Pharmaceuticals with the FDA for Neosalus Cream.
| Device ID | K090585 |
| 510k Number | K090585 |
| Device Name: | NEOSALUS CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | QUINNOVA PHARMACEUTICALS 411 S. STATE ST. 3RD. FLOOR Newtown, PA 18940 |
| Contact | Shahbaz Khan |
| Correspondent | Shahbaz Khan QUINNOVA PHARMACEUTICALS 411 S. STATE ST. 3RD. FLOOR Newtown, PA 18940 |
| 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 | 2009-03-04 |
| Decision Date | 2009-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381811000008 | K090585 | 000 |