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FDA 510(k) Application Details - K130027
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K130027
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
CATHAY MANUFACTURING CORP.
NO. 328, XISHE ROAD, MAOGANG TOWN, SONGJIANG AREA
SHANGHAI 201607 CN
Other 510(k) Applications for this Company
Contact
ZHANG HUI
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
01/03/2013
Decision Date
08/22/2013
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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