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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 K012715
Device Name HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
Applicant
Hygia Health Services, Inc.
2800 Milan Ct., Suite 259
Birmingham,  AL  35211
Applicant Contact TRACY COMAS
Correspondent
Hygia Health Services, Inc.
2800 Milan Ct., Suite 259
Birmingham,  AL  35211
Correspondent Contact TRACY COMAS
Regulation Number870.2700
Classification Product Code
NLF  
Date Received08/14/2001
Decision Date 08/01/2003
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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