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FDA 510(k) Application Details - K990715
Device Classification Name
System, X-Ray, Stationary
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510(K) Number
K990715
Device Name
System, X-Ray, Stationary
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
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Contact
MICHAEL FISHBACK
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Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
03/04/1999
Decision Date
04/16/1999
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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