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FDA 510(k) Application Details - K111644
Device Classification Name
Trocar
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1390
More FDA Info for this Regulation Number
Classification Product Code
DRC
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More FDA Info for this Product Code
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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