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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Airbrush
510(k) Number K903284
Device Name YOUNG PROPHY SYSTEM, PS UNIT
Applicant
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Applicant Contact SCOTT RICHMOND
Correspondent
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Correspondent Contact SCOTT RICHMOND
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received07/22/1990
Decision Date 12/17/1990
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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