FC-38LH, FIBER COLONOSCCOPE

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 Fc-38lh, Fiber Colonosccope.

Pre-market Notification Details

Device IDK951580
510k NumberK951580
Device Name:FC-38LH, FIBER COLONOSCCOPE
ClassificationColonoscope 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 CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-04
Decision Date1995-06-27

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