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FDA 510(k) Application Details - K080093
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K080093
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772 US
Other 510(k) Applications for this Company
Contact
TERRENCE E SULLIVAN
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2008
Decision Date
05/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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