FDA 510(k) Application Details - K111644

Device Classification Name Trocar

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510(K) Number K111644
Device Name Trocar
Applicant Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS, MN 55441 US
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Contact Kristi Fox
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 06/13/2011
Decision Date 10/03/2011
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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