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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
Applicant
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact LISA STONE
Correspondent
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact LISA STONE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/23/2000
Decision Date 04/27/2000
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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