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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K992648
Device Name ROTARY MASTER
Applicant
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.4200
Classification Product Code
EBW  
Date Received08/06/1999
Decision Date 01/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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