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FDA 510(k) Application Details - K101039
Device Classification Name
Collimator, Automatic, Radiographic
More FDA Info for this Device
510(K) Number
K101039
Device Name
Collimator, Automatic, Radiographic
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
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Contact
DON KARLE
Other 510(k) Applications for this Contact
Regulation Number
892.1610
More FDA Info for this Regulation Number
Classification Product Code
IZW
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More FDA Info for this Product Code
Date Received
04/14/2010
Decision Date
09/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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