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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 K161480
Device Name R2 Dermal Cooling System
Applicant
R2 Dermatology
Bishop Ranch 3 2633 Camino Ramon
San Ramon,  CA  94583
Applicant Contact Kristine Tatsutani
Correspondent
R2 Dermatology
Bishop Ranch 3 2633 Camino Ramon
San Ramon,  CA  94583
Correspondent Contact Kristine Tatsutani
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/31/2016
Decision Date 10/05/2016
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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