LAPAROSCOPE, HAND INSTRUMENTS

Laparoscope, General & Plastic Surgery

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Laparoscope, Hand Instruments.

Pre-market Notification Details

Device IDK950103
510k NumberK950103
Device Name:LAPAROSCOPE, HAND INSTRUMENTS
ClassificationLaparoscope, General & Plastic Surgery
Applicant OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-11
Decision Date1995-03-06

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