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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K932990
Device Name ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
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 Number872.4200
Classification Product Code
EFB  
Date Received06/18/1993
Decision Date 09/29/1993
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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