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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 K081927
Device Name RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
Applicant
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Applicant Contact L. BRUCE PIERSON
Correspondent
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Correspondent Contact L. BRUCE PIERSON
Regulation Number870.2700
Classification Product Code
NLF  
Date Received07/07/2008
Decision Date 02/06/2009
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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