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FDA 510(k) Application Details - K130305
Device Classification Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K130305
Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant
LINA MEDICAL APS
611 WEST 5TH STRRET
THIRD FLOOR
AUSTIN, TX 78701 US
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Contact
RICHARD GILLIS
Other 510(k) Applications for this Contact
Regulation Number
884.4150
More FDA Info for this Regulation Number
Classification Product Code
HIN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2013
Decision Date
07/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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