GODAT UTERINE MANIPULATOR INJECTOR

Cannula, Manipulator/injector, Uterine

IDEAS FOR MEDICINE, INC.

The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Godat Uterine Manipulator Injector.

Pre-market Notification Details

Device IDK935023
510k NumberK935023
Device Name:GODAT UTERINE MANIPULATOR INJECTOR
ClassificationCannula, Manipulator/injector, Uterine
Applicant IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactLorna K Linville
CorrespondentLorna K Linville
IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-20
Decision Date1995-01-04

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