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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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