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FDA 510(k) Application Details - K130497
Device Classification Name
Motor, Drill, Electric
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510(K) Number
K130497
Device Name
Motor, Drill, Electric
Applicant
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO, FL 33773 US
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Contact
JONATHAN WERNER
Other 510(k) Applications for this Contact
Regulation Number
882.4360
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Classification Product Code
HBC
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More FDA Info for this Product Code
Date Received
02/26/2013
Decision Date
03/29/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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