FE-24X, FIBER ESOPHAGOSCOPE

Esophagoscope, General & Plastic Surgery

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fe-24x, Fiber Esophagoscope.

Pre-market Notification Details

Device IDK951197
510k NumberK951197
Device Name:FE-24X, FIBER ESOPHAGOSCOPE
ClassificationEsophagoscope, General & Plastic Surgery
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 CodeGCL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-16
Decision Date1995-05-30

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