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FDA 510(k) Application Details - K061028
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
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510(K) Number
K061028
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N. GRANDVIEW BLVD.
W-440
WAUKESHA, WI 53188 US
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Contact
LARRY KROGER
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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
04/13/2006
Decision Date
06/07/2006
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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