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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K943157
Device Name ORAL-B ULTRAFLOSS WITH FLLUORIDE
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 Number872.6390
Classification Product Code
JES  
Date Received07/01/1994
Decision Date 04/27/1995
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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