FDA 510(k) Application Details - K112033

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K112033
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI, OH 45242 US
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Contact DONOVAN MAY
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/15/2011
Decision Date 11/08/2011
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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