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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 K893736
Device Name HOT BRUSH
Applicant
Home Dental Care, Inc.
P.O. Box 52
Rowayton,  CT  06853
Applicant Contact THOMAS F THORNTON
Correspondent
Home Dental Care, Inc.
P.O. Box 52
Rowayton,  CT  06853
Correspondent Contact THOMAS F THORNTON
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received05/17/1989
Decision Date 02/14/1990
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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