HYSTEROSCOPE (AND ACCESSORIES)

Hysteroscope (and Accessories)

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Hysteroscope (and Accessories).

Pre-market Notification Details

Device IDK921942
510k NumberK921942
Device Name:HYSTEROSCOPE (AND ACCESSORIES)
ClassificationHysteroscope (and Accessories)
Applicant OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine,  CA  92714
ContactRonald J Ehmsen
CorrespondentRonald J Ehmsen
OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine,  CA  92714
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-24
Decision Date1994-06-24

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