OES LAPARO-THORACO VIDEOSCOPE (RIGID)

Laparoscope, Gynecologic (and Accessories)

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Oes Laparo-thoraco Videoscope (rigid).

Pre-market Notification Details

Device IDK955456
510k NumberK955456
Device Name:OES LAPARO-THORACO VIDEOSCOPE (RIGID)
ClassificationLaparoscope, Gynecologic (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 CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-29
Decision Date1996-02-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761066815 K955456 000
04042761066709 K955456 000
04042761066501 K955456 000

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