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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 K190356
Device Name ClariFix
Applicant
Arrinex, Inc
127 Independence drive
Menlo Park,  CA  94025
Applicant Contact Tracey Henry
Correspondent
Arrinex, Inc
127 Independence drive
Menlo Park,  CA  94025
Correspondent Contact Tracey Henry
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/15/2019
Decision Date 02/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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