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FDA 510(k) Application Details - K031869
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K031869
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
723 CURTIS CT, SUITE A
SISTERS, OR 97759 US
Other 510(k) Applications for this Company
Contact
MARY ANN BARKER
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
06/17/2003
Decision Date
12/24/2003
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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