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FDA 510(k) Application Details - K092713
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K092713
Device Name
System, X-Ray, Mobile
Applicant
TRANSAMERICAN MEDICAL IMAGING
965 WEST 325 NORTH
LINDON, UT 84042 US
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Contact
ROBERT H WOODWARD
Other 510(k) Applications for this Contact
Regulation Number
892.1720
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Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
09/03/2009
Decision Date
07/16/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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