Dermal Cooling System

Unit, Cryosurgical, Accessories

R2 Technologies, Inc.

The following data is part of a premarket notification filed by R2 Technologies, Inc. with the FDA for Dermal Cooling System.

Pre-market Notification Details

Device IDK201260
510k NumberK201260
Device Name:Dermal Cooling System
ClassificationUnit, Cryosurgical, Accessories
Applicant R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon,  CA  94583
ContactRagan Reppond
CorrespondentRagan Reppond
R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon,  CA  94583
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2020-09-24

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