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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 K980995
Device Name PLAQ-ATAQ-I
Applicant
Ethicare
P.O. Box 5027
Ft. Lauderdale,  FL  33310
Applicant Contact SEYMOUR TROY
Correspondent
Ethicare
P.O. Box 5027
Ft. Lauderdale,  FL  33310
Correspondent Contact SEYMOUR TROY
Regulation Number872.6855
Classification Product Code
EFW  
Date Received02/27/1998
Decision Date 08/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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