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510(k) K091288

MEDI-6000 MEDICAL IMAGE DIGITIZER by Microtek International, Inc. — Product Code LMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2009
Date Received
May 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type

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