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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Reprocessed
510(k) Number K080424
Device Name HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
Applicant
Hygia Health Services, Inc.
434 Industrial Ln.
Birmingham,  AL  35211
Applicant Contact JEROME JAMES
Correspondent
Hygia Health Services, Inc.
434 Industrial Ln.
Birmingham,  AL  35211
Correspondent Contact JEROME JAMES
Regulation Number870.2700
Classification Product Code
NLF  
Date Received02/15/2008
Decision Date 05/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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