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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 K012657
Device Name HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
Applicant
HYGIA HEALTH SERVICES, INC.
2800 MILAN CT., SUITE 259
BIRMINGHAM,  AL  35211
Applicant Contact GEOFF M FATZINGER
Correspondent
HYGIA HEALTH SERVICES, INC.
2800 MILAN CT., SUITE 259
BIRMINGHAM,  AL  35211
Correspondent Contact GEOFF M FATZINGER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/13/2001
Decision Date 04/12/2002
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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