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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 K062999
Device Name OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2-2
LAKE FOREST,  IL  60045
Applicant Contact DIANE RENNPFERD
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2-2
LAKE FOREST,  IL  60045
Correspondent Contact DIANE RENNPFERD
Regulation Number870.1230
Classification Product Code
DQE  
Date Received10/02/2006
Decision Date 11/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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