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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K053049
Device Name ALARIS SAFETY MALE LUER
Applicant
CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO,  CA  92121 -2772
Applicant Contact STACY L LEWIS
Correspondent
CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO,  CA  92121 -2772
Correspondent Contact STACY L LEWIS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/28/2005
Decision Date 01/12/2006
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
Recalls CDRH Recalls
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