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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 K171398
Device Name Dermal Cooling System
Applicant
R2 Dermatology ,Inc
2633 Camino Ramon, Suite 130
San Ramon,  CA  94583
Applicant Contact Kristine Tatsutani
Correspondent
R2 Dermatology ,Inc
2633 Camino Ramon, Suite 130
San Ramon,  CA  94583
Correspondent Contact Bijesh Chandran
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/12/2017
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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