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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 K991255
Device Name CADD-TPN ADMINISTRATION SET, MODEL 21-7071
Original Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact edward w numainville
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/13/1999
Decision Date 06/09/1999
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
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