FC-38LX, FIBER COLONOSCOPE

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-38lx, Fiber Colonoscope.

Pre-market Notification Details

Device IDK951578
510k NumberK951578
Device Name:FC-38LX, FIBER COLONOSCOPE
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.