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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 K122425
Device Name VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
Original Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham,  MA  02767
Original Contact yayoi fujimaki
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/09/2012
Decision Date 11/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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