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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K162826
Device Name Encore Neutral
Applicant
RyMed Technologies, LLC
6000 W. William Cannon Drive B300
Austin,  TX  78749
Applicant Contact Anna McCutchen
Correspondent
RyMed Technologies, LLC
6000 W. William Cannon Drive B300
Austin,  TX  78749
Correspondent Contact Anna McCutchen
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/07/2016
Decision Date 06/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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