FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE

Choledochoscope And Accessories, Flexible/rigid

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fcn-15x, Fiber Choledochonephroscope.

Pre-market Notification Details

Device IDK951191
510k NumberK951191
Device Name:FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
ClassificationCholedochoscope And Accessories, Flexible/rigid
Applicant PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar,  FL  33025
ContactPaul Silva
CorrespondentPaul Silva
PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar,  FL  33025
Product CodeFBN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-16
Decision Date1995-05-30

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