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FDA 510(k) Application Details - K052790
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K052790
Device Name
Set, I.V. Fluid Transfer
Applicant
CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO, CA 92121-2772 US
Other 510(k) Applications for this Company
Contact
STACY L LEWIS
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
12/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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