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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K090882
Device Name FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
Applicant
Hospira, Inc.
275 N. Field Dr.
D-389, Bldg., H2
Lake Forest,  IL  60045
Applicant Contact KEITH DUNN
Correspondent
Hospira, Inc.
275 N. Field Dr.
D-389, Bldg., H2
Lake Forest,  IL  60045
Correspondent Contact KEITH DUNN
Regulation Number880.5200
Classification Product Code
NGT  
Date Received03/31/2009
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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