ARTHROSCOPE & ACCESSORIES

Arthroscope

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Arthroscope & Accessories.

Pre-market Notification Details

Device IDK921985
510k NumberK921985
Device Name:ARTHROSCOPE & ACCESSORIES
ClassificationArthroscope
Applicant OPTIMED TECHNOLOGIES, INC. 1441 N. BATAVIA STREETT, SUITE 114 Orange,  CA  92667
ContactRonald J Ehmsen
CorrespondentRonald J Ehmsen
OPTIMED TECHNOLOGIES, INC. 1441 N. BATAVIA STREETT, SUITE 114 Orange,  CA  92667
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-28
Decision Date1993-06-29

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