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FDA 510(k) Application Details - K051602
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
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510(K) Number
K051602
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN, PA 19355-1406 US
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Contact
GARY JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
892.1650
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Classification Product Code
JAA
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More FDA Info for this Product Code
Date Received
06/16/2005
Decision Date
07/07/2005
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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