MEDIVISION CYSTOSCOPE

Cystoscope And Accessories, Flexible/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 Cystoscope.

Pre-market Notification Details

Device IDK982620
510k NumberK982620
Device Name:MEDIVISION CYSTOSCOPE
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant MEDIVISION SCOPE SERVICE CENTER, INC. 1440 SOUTH STATE COLLEGE BLVD. SUITE 1C Anaheim,  CA  92806
ContactWayne B Sterner
CorrespondentWayne B Sterner
MEDIVISION SCOPE SERVICE CENTER, INC. 1440 SOUTH STATE COLLEGE BLVD. SUITE 1C Anaheim,  CA  92806
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-27
Decision Date1998-09-30

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