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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
Applicant
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact YAYOI FUJIMAKI
Correspondent
Depuy Mitek, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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