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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K162608
Device Name ClariFix Device
Applicant
ARRINEX, INC.
1755 EAST BAYSHORE RD, STE 26
REDWOOD CITY,  CA  94063
Applicant Contact VAHID SAADAT
Correspondent
ARRINEX, INC.
1755 EAST BAYSHORE RD, STE 26
REDWOOD CITY,  CA  94063
Correspondent Contact VAHID SAADAT
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/19/2016
Decision Date 02/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02820597
Reviewed by Third Party No
Combination Product No
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