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FDA 510(k) Application Details - K080701
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K080701
Device Name
System, X-Ray, Mobile
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
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Contact
DON KARLE
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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
03/11/2008
Decision Date
05/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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