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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Surgical And Accessories
510(k) Number K832342
Device Name ENDOSCOPIC CAMERA TV W/AUDIO
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 Number878.4160
Classification Product Code
KQM  
Date Received07/12/1983
Decision Date 09/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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