FDA 510(k) Application Details - K955689

Device Classification Name Instruments, Surgical, Cardiovascular

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510(K) Number K955689
Device Name Instruments, Surgical, Cardiovascular
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 870.4500

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Classification Product Code DWS
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Date Received 12/14/1995
Decision Date 05/15/1996
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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