SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS

Unit, Cryosurgical, Accessories

GALIL MEDICAL LTD.

The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet/seednetgold, Cryothera And Cryo-hit Systems.

Pre-market Notification Details

Device IDK060144
510k NumberK060144
Device Name:SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
ClassificationUnit, Cryosurgical, 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 CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-19
Decision Date2006-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290104830242 K060144 000
07290104830235 K060144 000

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