UTERINE MANIPULATORS

Instrument, Manual, General Obstetric-gynecologic

REZNIK INSTRUMENTS

The following data is part of a premarket notification filed by Reznik Instruments with the FDA for Uterine Manipulators.

Pre-market Notification Details

Device IDK812204
510k NumberK812204
Device Name:UTERINE MANIPULATORS
ClassificationInstrument, Manual, General Obstetric-gynecologic
Applicant REZNIK INSTRUMENTS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKOH  
CFR Regulation Number884.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-04
Decision Date1981-10-13

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