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FDA 510(k) Application Details - K090309
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K090309
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
LAGIS ENTERPRISES CO, LTD.
7128 STAFFORDSHIRE ST.
HOUSTON, TX 77030 US
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Contact
JOSEPH J CHANG
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
02/06/2009
Decision Date
08/28/2009
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
N
Expedited Review
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