Curasite
Dressing, Wound, Drug
IZUN PHARMACEUTICALS
The following data is part of a premarket notification filed by Izun Pharmaceuticals with the FDA for Curasite.
Pre-market Notification Details
| Device ID | K161991 |
| 510k Number | K161991 |
| Device Name: | Curasite |
| Classification | Dressing, Wound, Drug |
| Applicant | IZUN PHARMACEUTICALS ONE ROCKEFELLER PLAZA, 11TH FLOOR New York, NY 10020 |
| Contact | Jack Talley |
| Correspondent | Richard E. Lowenthal PACIFIC-LINK CONSULTING 8195 RUN OF THE KNOLLS COURT San Diego, CA 92127 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2017-03-03 |
Trademark Results [Curasite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURASITE 79197792 5202439 Live/Registered |
IZUN PHARMA LTD. 2016-07-10 |
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