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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 K982133
Device Name OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
Applicant
The Olympus Optical Co.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact RUTH C FORSTADT
Correspondent
The Olympus Optical Co.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact RUTH C FORSTADT
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/17/1998
Decision Date 10/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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