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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 K024105
Device Name VELOPEX AQUACUT FLUID ABRASION UNIT
Applicant
Velopex International, Inc.
105 E. 17th St.
St. Cloud,  FL  34769
Applicant Contact TONY URELLA
Correspondent
Velopex International, Inc.
105 E. 17th St.
St. Cloud,  FL  34769
Correspondent Contact TONY URELLA
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received12/13/2002
Decision Date 10/09/2003
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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