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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K901963
Device Name OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
Applicant
Omron Marshall Products, Inc.
600 Barclay Blvd.
Lincolnshire,  IL  60069
Applicant Contact CASEY GUZNICZAK
Correspondent
Omron Marshall Products, Inc.
600 Barclay Blvd.
Lincolnshire,  IL  60069
Correspondent Contact CASEY GUZNICZAK
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received05/01/1990
Decision Date 06/26/1990
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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