MIYA HOOK

Instrument, Manual, Specialized 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 Miya Hook.

Pre-market Notification Details

Device IDK891045
510k NumberK891045
Device Name:MIYA HOOK
ClassificationInstrument, Manual, Specialized 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 CodeKNA  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-28
Decision Date1989-03-22

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