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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 K832341
Device Name ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC
Applicant
Kamiya Tsusan Kaisha, Ltd.
Cpo Box 1590
Tokyo 100-91 Japan, 
Correspondent
Kamiya Tsusan Kaisha, Ltd.
Cpo Box 1590
Tokyo 100-91 Japan, 
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/12/1983
Decision Date 10/04/1983
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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