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FDA 510(k) Application Details - K092732
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K092732
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
BIO PROTECH, INC.
TAEJANG-2 DONG
WONJU-SI GANGWON-DO KR
Other 510(k) Applications for this Company
Contact
KEVIN HAN
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
09/04/2009
Decision Date
11/25/2009
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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