CANDELA MINI-UB ENDOSCOPE

Mini Endoscope, Gastroenterology-urology

CANDELA LASER CORP.

The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Mini-ub Endoscope.

Pre-market Notification Details

Device IDK910732
510k NumberK910732
Device Name:CANDELA MINI-UB ENDOSCOPE
ClassificationMini Endoscope, Gastroenterology-urology
Applicant CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactGeorge Cho
CorrespondentGeorge Cho
CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-21
Decision Date1991-04-12

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