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 IDK162695
510k NumberK162695
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 Received2016-09-27
Decision Date2016-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857068006068 K162695 000
00857068006051 K162695 000
10857068006058 K162695 000

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