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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saw, Bone, Ac-Powered
510(k) Number K935443
Device Name ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
Applicant
Osada Electric Co., Ltd.
8242 W. 3rd St., Suite 150
Los Angeles,  CA  90048
Applicant Contact YOSHINO CHARLENE HARA
Correspondent
Osada Electric Co., Ltd.
8242 W. 3rd St., Suite 150
Los Angeles,  CA  90048
Correspondent Contact YOSHINO CHARLENE HARA
Regulation Number872.4120
Classification Product Code
DZH  
Date Received11/12/1993
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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