OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE

Hysteroscope (and Accessories)

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Hyf-p Flexible Hysterofiberscope.

Pre-market Notification Details

Device IDK891451
510k NumberK891451
Device Name:OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
ClassificationHysteroscope (and Accessories)
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactJoseph R Williams
CorrespondentJoseph R Williams
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-15
Decision Date1989-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170340178 K891451 000
04953170307089 K891451 000
04953170058219 K891451 000
04953170051128 K891451 000
04953170411571 K891451 000
04953170411090 K891451 000

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