OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM

Laparoscope, General & Plastic Surgery

OLYMPUS AMERICA, INC.

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

Pre-market Notification Details

Device IDK963184
510k NumberK963184
Device Name:OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-14
Decision Date1996-12-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170025990 K963184 000
04953170025976 K963184 000

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