ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY

Laparoscope, General & Plastic Surgery

ZINNANTI SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Zsi Laparoscopes-general & Plastic Surgery.

Pre-market Notification Details

Device IDK926181
510k NumberK926181
Device Name:ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
ClassificationLaparoscope, General & Plastic Surgery
Applicant ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
ContactTrish Willging
CorrespondentTrish Willging
ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-08
Decision Date1993-12-17

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