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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 K991301
Device Name CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
Applicant
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact EDWARD W NUMAINVILLE
Correspondent
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact EDWARD W NUMAINVILLE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/16/1999
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
Recalls CDRH Recalls
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