FDA 510(k) Application Details - K960755

Device Classification Name Wire, Guide, Catheter

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510(K) Number K960755
Device Name Wire, Guide, Catheter
Applicant MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
4633 EAST LA PALMA AVE.
ANAHEIM, CA 92807 US
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Contact DEBRA KRIDNER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 02/23/1996
Decision Date 05/23/1996
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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