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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sleeve, limb, compressible
510(k) Number K122499
Device Name AIRCAST VENAFLOW ELITE SYSTEM
Original Applicant
DJO, LLC
1430 decision street
vista,  CA  92081 -8553
Original Contact ken fisher
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/16/2012
Decision Date 10/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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