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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, oximeter, fiber-optic
510(k) Number K061159
Device Name OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Applicant Contact THOMAS KOZMA
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Regulation Number870.1230
Classification Product Code
DQE  
Date Received04/26/2006
Decision Date 06/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product Yes
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