TruFreeze System

Unit, Cryosurgical, Accessories

CSA Medical, Inc.

The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Trufreeze System.

Pre-market Notification Details

Device IDK172041
510k NumberK172041
Device Name:TruFreeze System
ClassificationUnit, Cryosurgical, Accessories
Applicant CSA Medical, Inc. 91 Hartwell Avenue Lexington,  MA  02421
ContactSherrie Coval-goldsmith
CorrespondentSherrie Coval-goldsmith
CSA Medical, Inc. 91 Hartwell Avenue Lexington,  MA  02421
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-06
Decision Date2017-07-27
Summary:summary

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