MINI-UB ENDOSCOPES

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 Mini-ub Endoscopes.

Pre-market Notification Details

Device IDK941230
510k NumberK941230
Device Name:MINI-UB ENDOSCOPES
ClassificationMini Endoscope, Gastroenterology-urology
Applicant CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactJoseph Lowery
CorrespondentJoseph Lowery
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 Received1994-03-15
Decision Date1994-06-17

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