FDA 510(k) Application Details - K132645

Device Classification Name Retractor

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510(K) Number K132645
Device Name Retractor
Applicant MEDTRONIC, INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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Contact CHELSEA PIOSKE
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Regulation Number 878.4800

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Classification Product Code GAD
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Date Received 08/23/2013
Decision Date 10/04/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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