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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 K042696
Device Name BODYGUARD INFUSION PUMP SYSTEM
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
INDUSTRIAL PARK
CAESAREA,  IL 38900
Applicant Contact GALI TZURY
Correspondent
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
INDUSTRIAL PARK
CAESAREA,  IL 38900
Correspondent Contact GALI TZURY
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MEA  
Date Received09/30/2004
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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