PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P

Cystoscope 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 Pentax Cystofiberscope, Model Fcy-15p.

Pre-market Notification Details

Device IDK914008
510k NumberK914008
Device Name:PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg,  NY  10962
ContactLorraine Schwartz
CorrespondentLorraine Schwartz
PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg,  NY  10962
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-09
Decision Date1992-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333243419 K914008 000
04961333232734 K914008 000
04961333232413 K914008 000
04961333232406 K914008 000
04961333232390 K914008 000
04961333228058 K914008 000
04961333224951 K914008 000
04961333246465 K914008 000
04961333084463 K914008 000

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