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510(k) K093503

INTRAX FILM PROCESSOR by Velopex International, Inc. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2010
Date Received
November 12, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

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