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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K951354
Device Name OLYMPUS ARTHROSCOPY SYSTEM
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact SUBHASH R PATEL
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact SUBHASH R PATEL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/24/1995
Decision Date 06/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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