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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 K040636
Device Name CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact PATRICIA A LAFORTE
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact PATRICIA A LAFORTE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/10/2004
Decision Date 05/19/2004
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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