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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 K130722
Device Name AIRCAST VENAFLOW ELITE SYSTEM
Applicant
DJO, LLC
1430 DECISION STREET
VISTA,  CA  92081 -8553
Applicant Contact LORRI TROTTER
Correspondent
DJO, LLC
1430 DECISION STREET
VISTA,  CA  92081 -8553
Correspondent Contact LORRI TROTTER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/18/2013
Decision Date 06/20/2013
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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