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FDA 510(k) Application Details - K955684
Device Classification Name
Injector And Syringe, Angiographic
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510(K) Number
K955684
Device Name
Injector And Syringe, Angiographic
Applicant
CONTOUR FABRICATORS OF FLORIDA, INC.
1247 FLORIDA AVE.
PALM HARBOR, FL 34683 US
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Contact
PATRICK J LAMB
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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
12/14/1995
Decision Date
05/02/1996
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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