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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
Device Name RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
Applicant
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Applicant Contact BRUCE PIERSON
Correspondent
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Correspondent Contact BRUCE PIERSON
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/16/2012
Decision Date 06/12/2012
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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