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FDA 510(k) Application Details - K080581
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K080581
Device Name
System, X-Ray, Tomography, Computed
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034 US
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Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2008
Decision Date
10/16/2008
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
N
Expedited Review
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