A4722 OLYMPUS OPTICAL OBTURATOR

Hysteroscope (and Accessories)

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for A4722 Olympus Optical Obturator.

Pre-market Notification Details

Device IDK950055
510k NumberK950055
Device Name:A4722 OLYMPUS OPTICAL OBTURATOR
ClassificationHysteroscope (and Accessories)
Applicant OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-06
Decision Date1995-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761006682 K950055 000
04042761006521 K950055 000

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