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FDA 510(k) Application Details - K101990
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K101990
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI, OH 45242 US
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DONOVAN MAY
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Regulation Number
878.4400
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Classification Product Code
GEI
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Date Received
07/15/2010
Decision Date
06/13/2011
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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