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FDA 510(k) Application Details - K111285
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K111285
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
SALIENT SURGICAL TECHNOLOGIES, INC.
180 INTERNATIONAL DRIVE
PORTSMOUTH, NH 03801 US
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Contact
RITA M CALNAN
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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
05/06/2011
Decision Date
09/09/2011
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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