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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Contact Cooling For Skin Lesion Pain Relief
510(k) Number K213294
Device Name Dermal Cooling System
Applicant
R2 Technologies, Inc.
2603 Camino Ramon, Suite 200
San Ramon,  CA  94583
Applicant Contact Ragan Reppond
Correspondent
R2 Technologies, Inc.
2603 Camino Ramon, Suite 200
San Ramon,  CA  94583
Correspondent Contact Tarhan Kayihan
Regulation Number878.4340
Classification Product Code
QPZ  
Subsequent Product Codes
GED   ILO  
Date Received10/01/2021
Decision Date 11/10/2022
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
Predetermined Change
Control Plan Authorized		 No
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