SEEDNET, MODELS FP6T5, FP5T5, FP5T3

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, Models Fp6t5, Fp5t5, Fp5t3.

Pre-market Notification Details

Device IDK010991
510k NumberK010991
Device Name:SEEDNET, MODELS FP6T5, FP5T5, FP5T3
ClassificationUnit, Cryosurgical, Accessories
Applicant GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
ContactJohathan S Kahan
CorrespondentJohathan 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 Received2001-04-03
Decision Date2001-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290104830525 K010991 000
07290104830518 K010991 000
07290104830068 K010991 000

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