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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 K001629
Device Name DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
Applicant
DISETRONIC MEDICAL SYSTEMS AG
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Applicant Contact Lee Leichter
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Correspondent Contact Lee Leichter
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/26/2000
Decision Date 06/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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