CYSTOSCOPES

Cystoscope And Accessories, Flexible/rigid

GLOBAL ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Global Endoscopy, Inc. with the FDA for Cystoscopes.

Pre-market Notification Details

Device IDK003807
510k NumberK003807
Device Name:CYSTOSCOPES
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg,  IL  60193 -4426
ContactNick Mircea
CorrespondentNick Mircea
GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg,  IL  60193 -4426
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-08
Decision Date2001-02-22

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