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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 K963009
Device Name DELTEC SUBCUTANEOUS INFUSION SET
Original Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact david h short, rn,bs
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/02/1996
Decision Date 10/18/1996
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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