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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Surgical, General & Plastic Surgery
510(k) Number K110355
Device Name VENX REVOLUTION
Applicant
Venx, LLC
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact IRA DUESLER
Correspondent
Venx, LLC
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact IRA DUESLER
Regulation Number878.4800
Classification Product Code
GAH  
Date Received02/07/2011
Decision Date 04/22/2011
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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