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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 K061585
Device Name OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
DEPT. 389
LAKE FOREST,  IL  60045
Applicant Contact NICOHL WILDING
Correspondent
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
DEPT. 389
LAKE FOREST,  IL  60045
Correspondent Contact NICOHL WILDING
Regulation Number870.1230
Classification Product Code
DQE  
Date Received06/07/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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