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FDA 510(k) Application Details - K963982
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K963982
Device Name
Injector And Syringe, Angiographic
Applicant
INVASATEC
10180 VIKING LN.
EDEN PRAIRIE, MN 55344 US
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Contact
DOUG DUCHON
Other 510(k) Applications for this Contact
Regulation Number
870.1650
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Classification Product Code
DXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/02/1996
Decision Date
12/05/1997
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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