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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K120095
Models 228203, 228300, 228305, 228370, 228504
Device Name SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
Original Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham,  MA  02767
Original Contact susan kagan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/12/2012
Decision Date 04/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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