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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 K103017
Device Name MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
Applicant
Mederi Therapeutics, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact CURT RAYMOND
Correspondent
Mederi Therapeutics, Inc.
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact CURT RAYMOND
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/12/2010
Decision Date 01/20/2011
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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