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FDA 510(k) Application Details - K050489
Device Classification Name
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510(K) Number
K050489
Device Name
INNOVA 2100
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact
LARRY A KROGER
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Regulation Number
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Classification Product Code
OWB
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Date Received
02/25/2005
Decision Date
03/11/2005
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
Y
Expedited Review
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