FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE

Nasopharyngoscope (flexible Or Rigid)

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber-optic Nasopharyngoscope.

Pre-market Notification Details

Device IDK895245
510k NumberK895245
Device Name:FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine,  CA  92714
ContactEhmsen, Scd
CorrespondentEhmsen, Scd
OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine,  CA  92714
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-21
Decision Date1989-11-17

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