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 IDK171626
510k NumberK171626
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-02
Decision Date2017-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10724995199330 K171626 000
10724995199323 K171626 000
10724995199286 K171626 000
10724995199224 K171626 000
10724995199217 K171626 000
10724995199200 K171626 000
00724995199296 K171626 000

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