AED CYSTOSCOPE

Cystoscope And Accessories, Flexible/rigid

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Cystoscope.

Pre-market Notification Details

Device IDK993689
510k NumberK993689
Device Name:AED CYSTOSCOPE
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles,  CA  90064
ContactGayle M Butler
CorrespondentGayle M Butler
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles,  CA  90064
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-01
Decision Date1999-12-15

NIH GUDID Devices

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