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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 K033301
Device Name IV ADMINISTRATION AND CONNECT SETS
Applicant
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Applicant Contact ROHIT PATEL
Correspondent
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Correspondent Contact ROHIT PATEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/14/2003
Decision Date 03/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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