EG-2940, VIDEO GASTROSCOPE

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 Eg-2940, Video Gastroscope.

Pre-market Notification Details

Device IDK961564
510k NumberK961564
Device Name:EG-2940, VIDEO GASTROSCOPE
ClassificationGastroscope 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 CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-23
Decision Date1996-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333243389 K961564 000
04961333232437 K961564 000
04961333228324 K961564 000
04961333224586 K961564 000
04961333169030 K961564 000
04961333084265 K961564 000
04961333076420 K961564 000
04961333085538 K961564 000
04961333079346 K961564 000

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