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FDA 510(k) Application Details - K134036
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K134036
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP
816 CONGRESS AVE, STE 1400
AUSTIN, TX 78701 US
Other 510(k) Applications for this Company
Contact
Carrie Hetrick
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2013
Decision Date
10/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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