NEEDLE EXTENSIONS

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 Needle Extensions.

Pre-market Notification Details

Device IDK891035
510k NumberK891035
Device Name:NEEDLE EXTENSIONS
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 Received1989-02-28
Decision Date1989-03-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.