FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

Ureteroscope And Accessories, Flexible/rigid

RICHARD WOLF MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Flexible Fiberscope, Model 7331.001, Guide Section For Lithovac Handpiece, Model 8708.253.

Pre-market Notification Details

Device IDK991178
510k NumberK991178
Device Name:FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills,  IL  60061
ContactRpbert L Casarsa
CorrespondentRpbert L Casarsa
RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills,  IL  60061
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-07
Decision Date1999-06-11
Summary:summary

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