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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 K063661
Device Name RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
Applicant
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Applicant Contact BRUCE PIERSON
Correspondent
RENU MEDICAL, INC.
9800 EVERGREEN WAY
EVERETT,  WA  98204
Correspondent Contact BRUCE PIERSON
Regulation Number870.2700
Classification Product Code
NLF  
Date Received12/08/2006
Decision Date 05/25/2007
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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