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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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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