MEDIVISION SINOSCOPE

Nasopharyngoscope (flexible Or Rigid)

MEDIVISION SCOPE SERVICE CENTER, INC.

The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Sinoscope.

Pre-market Notification Details

Device IDK971995
510k NumberK971995
Device Name:MEDIVISION SINOSCOPE
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant MEDIVISION SCOPE SERVICE CENTER, INC. 1440 S. STATE COLLEGE BLVD. #1D Anaheim,  CA  92806
ContactWayne B Sterner
CorrespondentWayne B Sterner
MEDIVISION SCOPE SERVICE CENTER, INC. 1440 S. STATE COLLEGE BLVD. #1D Anaheim,  CA  92806
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-30
Decision Date1997-06-26

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