FDA 510(k) Application Details - K122832

Device Classification Name Trocar

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510(K) Number K122832
Device Name Trocar
Applicant Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS, MN 55441 US
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Contact DENISE THOMPSON
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 09/17/2012
Decision Date 12/19/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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