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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K131571
Device Name AVD RIGHT RADIAL DRAPE
Applicant
Advanced Vascular Dynamics
4252 SE International Way, Suite F
Milwaukie,  OR  97222
Applicant Contact MATTHEW SEMLER
Correspondent
Advanced Vascular Dynamics
4252 SE International Way, Suite F
Milwaukie,  OR  97222
Correspondent Contact MATTHEW SEMLER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/30/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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