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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 K882572
Device Name DOCTOR KOLYNOS TOOTHBRUSH
Applicant
Whitehall Laboratories, Inc.
685 Third Ave.
New York,  NY  10017
Applicant Contact KENNETH R PALMER
Correspondent
Whitehall Laboratories, Inc.
685 Third Ave.
New York,  NY  10017
Correspondent Contact KENNETH R PALMER
Regulation Number872.6855
Classification Product Code
EFW  
Date Received06/22/1988
Decision Date 04/17/1989
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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