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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 K954870
Device Name SIMS DELTEC ANTI-SIPHON VALVE
Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Applicant Contact david short
Correspondent
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Correspodent Contact david short
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/24/1995
Decision Date 12/15/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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