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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K071108
Device Name TEXIUM SYRINGE
Applicant
Cardinal Health, Alaris Products
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact STACY L LEWIS
Correspondent
Cardinal Health, Alaris Products
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact STACY L LEWIS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/19/2007
Decision Date 05/24/2007
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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