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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Blood Pressure Cuff
510(k) Number K032821
Device Name HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
Applicant
Hygia Health Services, Inc.
434 Industrial Ln.
Birmingham,  AL  35211
Applicant Contact TRACY W COMAS
Correspondent
Hygia Health Services, Inc.
434 Industrial Ln.
Birmingham,  AL  35211
Correspondent Contact TRACY W COMAS
Regulation Number870.1120
Classification Product Code
NPP  
Date Received09/05/2003
Decision Date 12/05/2003
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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