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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pick, Massaging
510(k) Number K942633
Device Name ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
Applicant
Oral-B Laboratories
One Lagoon Dr.
Redwood City,  CA  94065
Applicant Contact SHARON SNYDER
Correspondent
Oral-B Laboratories
One Lagoon Dr.
Redwood City,  CA  94065
Correspondent Contact SHARON SNYDER
Regulation Number872.6650
Classification Product Code
JET  
Date Received06/03/1994
Decision Date 04/27/1995
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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