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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 K031749
Device Name BODYGUARD INFUSION SYSTEM
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
CAESAREA INDUSTRIAL PARK
CAESAREA,  IL 38900
Applicant Contact GALI TZURY
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact CHRIS LAVANCHY
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received06/05/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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