The following data is part of a premarket notification filed by Izun Pharmaceuticals with the FDA for Curasite.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CURASITE 79197792 5202439 Live/Registered |
IZUN PHARMA LTD. 2016-07-10 |