PENTAX FC-38LA & FC-38SA COLONOFIBER

Colonoscope 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 Fc-38la & Fc-38sa Colonofiber.

Pre-market Notification Details

Device IDK822846
510k NumberK822846
Device Name:PENTAX FC-38LA & FC-38SA COLONOFIBER
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-23
Decision Date1982-10-22

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