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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K052790
Device Name SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
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 Number880.5440
Classification Product Code
LHI  
Date Received10/03/2005
Decision Date 12/23/2005
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
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