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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K895345
Device Name ORAD TOOTHBRUSH CLEANER
Applicant
Orad, Inc.
1320 Standiford
Suite 246
Modesto,  CA  95350
Applicant Contact WOLFE
Correspondent
Orad, Inc.
1320 Standiford
Suite 246
Modesto,  CA  95350
Correspondent Contact WOLFE
Regulation Number872.3520
Classification Product Code
EFT  
Date Received08/31/1989
Decision Date 03/07/1990
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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