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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K961486
Device Name IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
Applicant
Ivac Medical Systems
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
Ivac Medical Systems
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received04/15/1996
Decision Date 04/17/1998
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
Predetermined Change
Control Plan Authorized		 No
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