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FDA 510(k) Application Details - K051956
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K051956
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
SOMETECH INCORPORATED
2F, BYUKSAN DIGITAL VALLEY III
212-13, GURODONG, GURO-KU
SEOUL 152-050 KR
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Contact
YOUNG-SOO SEOL
Other 510(k) Applications for this Contact
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
07/19/2005
Decision Date
09/08/2005
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
Y
Expedited Review
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