FDA 510(k) Application Details - K041338

Device Classification Name Stabilizer,Heart

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510(K) Number K041338
Device Name Stabilizer,Heart
Applicant MEDTRONIC VASCULAR
7601 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
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Contact SCOTT CUNDY
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Regulation Number 870.4500

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Classification Product Code MWS
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Date Received 05/20/2004
Decision Date 07/19/2004
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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