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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 K933829
Device Name PULSE ELECTRIC TOOTHBRUSH
Applicant
Dentatech Corp.
15 Keele St. S.
Unit #2
King City, Ontario,  CA LOG 1KO
Applicant Contact ROBERT G DICKIE
Correspondent
Dentatech Corp.
15 Keele St. S.
Unit #2
King City, Ontario,  CA LOG 1KO
Correspondent Contact ROBERT G DICKIE
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received08/05/1993
Decision Date 12/13/1993
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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