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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 K925408
Device Name ORAL-B DENTAL TAPE 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 Number872.6390
Classification Product Code
JES  
Date Received10/26/1992
Decision Date 01/28/1993
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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