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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 K161378
Device Name joimax Electrosurgical Instruments
Applicant
Joimax GmbH
Amalienbadstr. 41, Raumfabrik 61
Karlsruhe,  DE 76227
Applicant Contact WOLFGANG RIES
Correspondent
Gary S. Mocnik and Associates
49 Coastal Oak
Aliso Viejo,  CA  92656
Correspondent Contact GARY MOCNIK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/18/2016
Decision Date 11/02/2016
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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