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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 K000942
Device Name CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
Original Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact lisa stone
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/23/2000
Decision Date 04/27/2000
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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