FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE

Hysteroscope (and Accessories)

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber Optic Gynecologic Endoscope.

Pre-market Notification Details

Device IDK922711
510k NumberK922711
Device Name:FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE
ClassificationHysteroscope (and Accessories)
Applicant OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange,  CA  92665
ContactRonald Ehmsen
CorrespondentRonald Ehmsen
OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange,  CA  92665
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-05
Decision Date1994-05-17

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