OPTIK LAPAROSCOPE

Laparoscope, General & Plastic Surgery

OPTIK

The following data is part of a premarket notification filed by Optik with the FDA for Optik Laparoscope.

Pre-market Notification Details

Device IDK933776
510k NumberK933776
Device Name:OPTIK LAPAROSCOPE
ClassificationLaparoscope, General & Plastic Surgery
Applicant OPTIK 1370 BLAIR DR. Odenton,  MD  21113
ContactWilliam M Macfie
CorrespondentWilliam M Macfie
OPTIK 1370 BLAIR DR. Odenton,  MD  21113
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-03
Decision Date1994-03-16

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