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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 K051227
Device Name RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
Applicant
Renu Medical, Inc.
9800 Evergreen Way
Everett,  WA  98204
Applicant Contact GEORGE BIGGINS
Correspondent
Renu Medical, Inc.
9800 Evergreen Way
Everett,  WA  98204
Correspondent Contact GEORGE BIGGINS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/12/2005
Decision Date 04/07/2006
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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