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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 K042693
Device Name IV ADMINISTRATION SET B400 SP
Applicant
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA,  CA  92704 -6944
Applicant Contact ROHIT PATEL
Correspondent
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA,  CA  92704 -6944
Correspondent Contact ROHIT PATEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/30/2004
Decision Date 10/21/2004
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
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