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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K053420
Device Name TENACORE SP02 SENSORS
Applicant
TENACORE HOLDINGS, INC.
647 EAST YOUNG ST.
SANTA ANA,  CA  92705
Applicant Contact Brand Caso
Correspondent
TENACORE HOLDINGS, INC.
647 EAST YOUNG ST.
SANTA ANA,  CA  92705
Correspondent Contact Brand Caso
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/08/2005
Decision Date 11/15/2006
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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