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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 K122640
Device Name VPULSE
Original Applicant
1331 h street nw
12th floor
washington,  DC  20005
Original Contact justin eggleton
Regulation Number870.5800
Classification Product Code
Date Received08/29/2012
Decision Date 02/22/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No