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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K161991
Device Name Curasite
Applicant
IZUN PHARMACEUTICALS
ONE ROCKEFELLER PLAZA, 11TH FLOOR
NEW YORK,  NY  10020
Applicant Contact JACK TALLEY
Correspondent
PACIFIC-LINK CONSULTING
8195 RUN OF THE KNOLLS COURT
SAN DIEGO,  CA  92127
Correspondent Contact RICHARD E. LOWENTHAL
Classification Product Code
FRO  
Date Received07/19/2016
Decision Date 03/03/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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