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FDA 510(k) Application Details - K123141
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K123141
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI, OH 45242 US
Other 510(k) Applications for this Company
Contact
EMILY KREUTZKAMP
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
10/05/2012
Decision Date
10/25/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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