OLYMPUS ARTHROSCOPY SYSTEM

Arthroscope

OLYMPUS AMERICA, INC.

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

Pre-market Notification Details

Device IDK951354
510k NumberK951354
Device Name:OLYMPUS ARTHROSCOPY SYSTEM
ClassificationArthroscope
Applicant OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
ContactSubhash R Patel
CorrespondentSubhash R Patel
OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-24
Decision Date1995-06-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847399005830 K951354 000
04042761010542 K951354 000
04042761010559 K951354 000
04042761010627 K951354 000
04042761010634 K951354 000
04042761010641 K951354 000
04042761010658 K951354 000
04042761010955 K951354 000
04042761010962 K951354 000
04042761010979 K951354 000
04042761010986 K951354 000
00847399005823 K951354 000
04042761010535 K951354 000

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