PENTAX FG-34JA GASTROFIBERSCOPE

Gastroscope 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 Fg-34ja Gastrofiberscope.

Pre-market Notification Details

Device IDK832007
510k NumberK832007
Device Name:PENTAX FG-34JA GASTROFIBERSCOPE
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-23
Decision Date1983-08-11

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