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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
Applicant
Djo, LLC
1430 Decision St.
Vista,  CA  92081 -8553
Applicant Contact KEN FISHER
Correspondent
Djo, LLC
1430 Decision St.
Vista,  CA  92081 -8553
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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