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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K093503
Device Name INTRAX FILM PROCESSOR
Applicant
Velopex International, Inc.
105 E. 17th St.
St. Cloud,  FL  34769
Applicant Contact ANTHONY URELLA
Correspondent
Velopex International, Inc.
105 E. 17th St.
St. Cloud,  FL  34769
Correspondent Contact ANTHONY URELLA
Regulation Number892.1900
Classification Product Code
IXW  
Date Received11/12/2009
Decision Date 01/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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