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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 K990711
Device Name CODAN CHEMOSPIKE
Applicant
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Applicant Contact FERGIE FERGUSON
Correspondent
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Correspondent Contact FERGIE FERGUSON
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/04/1999
Decision Date 04/13/1999
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
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