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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 K053575
Device Name HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
Applicant
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211
Applicant Contact KYLE FERGUSON
Correspondent
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211
Correspondent Contact KYLE FERGUSON
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/22/2005
Decision Date 02/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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