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FDA 510(k) Application Details - K130760
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K130760
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD
NO. 631 XINGONG VILLAGE
EAST SIDE OF 2ND FL OF SOUTH BLDG
BEIJING 100069 CN
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LIGANG MAO
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Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
03/20/2013
Decision Date
09/16/2013
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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