EC-3800L, VIDEO 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 Ec-3800l, Video Colonoscope.

Pre-market Notification Details

Device IDK951574
510k NumberK951574
Device Name:EC-3800L, VIDEO 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 Date1996-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333232338 K951574 000
04961333232321 K951574 000
04961333232307 K951574 000
04961333232291 K951574 000
04961333224920 K951574 000
04961333134069 K951574 000
04961333113309 K951574 000
04961333079551 K951574 000

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