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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 K852400
Device Name PLAK SMACKER
Applicant
Plak Smacker Toothbrush Co.
1237-A W. Sixth St.
Corna,  CA  91720
Applicant Contact CLAUDETTE TAPOCIK
Correspondent
Plak Smacker Toothbrush Co.
1237-A W. Sixth St.
Corna,  CA  91720
Correspondent Contact CLAUDETTE TAPOCIK
Regulation Number872.6855
Classification Product Code
EFW  
Date Received06/06/1985
Decision Date 07/01/1985
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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