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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 K081559
Device Name GENESIS
Applicant
Medisiss
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI JAMES
Correspondent
Medisiss
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI JAMES
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/03/2008
Decision Date 08/28/2008
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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