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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 K041867
Device Name HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
Applicant
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211
Applicant Contact TRACY WOOD COMAS
Correspondent
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211
Correspondent Contact TRACY WOOD COMAS
Regulation Number870.2700
Classification Product Code
NLF  
Date Received07/09/2004
Decision Date 09/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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