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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 K091268
Device Name HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact DANIELA WEKSLER
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact DANIELA WEKSLER
Regulation Number870.1230
Classification Product Code
DQE  
Subsequent Product Codes
DYG   KRB  
Date Received04/30/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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