FDA 510(k) Application Details - K955685

Device Classification Name Injector And Syringe, Angiographic

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510(K) Number K955685
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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Date Received 12/14/1995
Decision Date 10/04/1996
Decision SESE - SUBST EQUIV
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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