VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT

Instrument, Manual, General Obstetric-gynecologic

ZINNANTI SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Vaginal Specula: Cusco, Guttman, Infant.

Pre-market Notification Details

Device IDK892693
510k NumberK892693
Device Name:VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
ClassificationInstrument, Manual, General Obstetric-gynecologic
Applicant ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
ContactAnna Straight
CorrespondentAnna Straight
ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
Product CodeKOH  
CFR Regulation Number884.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-13
Decision Date1989-05-11

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