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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 K121145
Model 3000 SERIES
Device Name RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
Original Applicant
RENU MEDICAL, INC.
9800 evergreen way
everett,  WA  98204
Original Contact bruce pierson
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/16/2012
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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