ROLLER ELECTRODE

Hysteroscope (and Accessories)

OLYMPUS AMERICA, INC.

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

Pre-market Notification Details

Device IDK954488
510k NumberK954488
Device Name:ROLLER ELECTRODE
ClassificationHysteroscope (and Accessories)
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-27
Decision Date1997-03-06

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