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FDA 510(k) Application Details - K011991
Device Classification Name
Injector And Syringe, Angiographic
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510(K) Number
K011991
Device Name
Injector And Syringe, Angiographic
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
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Contact
LORRAINE R FREDES
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Regulation Number
870.1650
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Classification Product Code
DXT
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More FDA Info for this Product Code
Date Received
06/26/2001
Decision Date
08/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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