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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K000842
Device Name CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
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 Number880.5725
Classification Product Code
FRN  
Date Received03/15/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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