Visual-ICE Cryoablation System, Software Revision 1.3.1

Unit, Cryosurgical, Accessories

GALIL MEDICAL INC.

The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Visual-ice Cryoablation System, Software Revision 1.3.1.

Pre-market Notification Details

Device IDK143564
510k NumberK143564
Device Name:Visual-ICE Cryoablation System, Software Revision 1.3.1
ClassificationUnit, Cryosurgical, Accessories
Applicant GALIL MEDICAL INC. 4264 Round Lake Road Arden Hills,  MN  55112
ContactAmy Mckinney
CorrespondentAmy Mckinney
GALIL MEDICAL INC. 6518 TAMARIND SKY LN Fulshear,  TX  77441
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-16
Decision Date2015-03-05
Summary:summary

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