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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K890812
Device Name HEADS TRUE BRUSH
Applicant
Mcs Trading Co.
15223 E. Gale Ave.
Industry,  CA  91745
Applicant Contact SUSILO LUKMAN
Correspondent
Mcs Trading Co.
15223 E. Gale Ave.
Industry,  CA  91745
Correspondent Contact SUSILO LUKMAN
Regulation Number872.6855
Classification Product Code
EFW  
Date Received02/16/1989
Decision Date 03/17/1989
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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