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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 K143662
Device Name Bissinger Monopolar Forceps and Cables
Applicant
Medagent, Inc.
112 Corporate Dr., Unit 1
Portsmouth,  NH  03801
Applicant Contact Franz Menean
Correspondent
Medagent, Inc.
112 Corporate Dr., Unit 1
Portsmouth,  NH  03801
Correspondent Contact Franz Menean
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2014
Decision Date 03/12/2015
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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