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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 K040416
FOIA Releasable 510(k) K040416
Device Name SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
Applicant
Philips Oral Healthcare, Inc.
35301 SE Center St.
Snoqualmie,  WA  98065
Applicant Contact ROSE DEGIACOMO
Correspondent
Philips Oral Healthcare, Inc.
35301 SE Center St.
Snoqualmie,  WA  98065
Correspondent Contact ROSE DEGIACOMO
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received02/18/2004
Decision Date 07/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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