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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K844339
Device Name BRAUN DENTAL CENTER OC-3
Applicant
The Braun Corp.
Prudential Tower
Boston,  MA  02199
Applicant Contact RODSER LONSLEY
Correspondent
The Braun Corp.
Prudential Tower
Boston,  MA  02199
Correspondent Contact RODSER LONSLEY
Regulation Number872.6510
Classification Product Code
EFS  
Date Received11/08/1984
Decision Date 02/08/1985
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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