MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY

Laparoscope, General & Plastic Surgery

UNISURGE, INC.

The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Manual Surgical Instrments For Laparoscopy.

Pre-market Notification Details

Device IDK915372
510k NumberK915372
Device Name:MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY
ClassificationLaparoscope, General & Plastic Surgery
Applicant UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View,  CA  94043
ContactCharles L Rose
CorrespondentCharles L Rose
UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View,  CA  94043
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-27
Decision Date1992-04-06

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