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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 K101534
Device Name CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
Applicant
Conmedcorp
14603 E. Fremont Ave.
Centennial,  CO  80112
Applicant Contact SHAWN REIDEL
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/03/2010
Decision Date 11/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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