FDA 510(k) Application Details - K140896

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K140896
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact SUSAN KAGAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/08/2014
Decision Date 08/05/2014
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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