CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

Electrosurgical, Cutting & Coagulation & Accessories

GALIL MEDICAL LTD.

The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Cryo-hit Model Numbers Ep3t3, Ep5t2, Ep5t5, Ep7t5, Ep8t5.

Pre-market Notification Details

Device IDK980913
510k NumberK980913
Device Name:CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-10
Decision Date1998-07-01
Summary:summary

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