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FDA 510(k) Application Details - K984058
Device Classification Name
Injector, Contrast Medium, Automatic
More FDA Info for this Device
510(K) Number
K984058
Device Name
Injector, Contrast Medium, Automatic
Applicant
ACIST MEDICAL SYSTEMS
10250 VALLEY VIEW RD., #117
EDEN PRAIRIE, MN 55344 US
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Contact
KATE ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
IZQ
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More FDA Info for this Product Code
Date Received
11/13/1998
Decision Date
02/11/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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