PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A

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 Pentax Choledochofiberscope, #fcd-15a.

Pre-market Notification Details

Device IDK821974
510k NumberK821974
Device Name:PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
ClassificationCholedochoscope And Accessories, Flexible/rigid
Applicant PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFBN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-02
Decision Date1982-08-10

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