FDA 510(k) Application Details - K042206

Device Classification Name Plasma, Coagulation Control

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510(K) Number K042206
Device Name Plasma, Coagulation Control
Applicant MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
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Contact DAWN STENSTROM
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Regulation Number 864.5425

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Classification Product Code GGN
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Date Received 08/16/2004
Decision Date 10/18/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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