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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K091139
Device Name CONMED AER DEFENSE SMOKE EVACUATOR
Applicant
Conmed Corporation
14603 E. Fremont Ave.
Centennial,  CO  80112
Applicant Contact DEMARIS VELEZ
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.5070
Classification Product Code
FYD  
Date Received04/20/2009
Decision Date 05/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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