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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 K070718
Device Name MODIFICATION TO: BODYGUARD INFUSION SYSTEM
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
INDUSTRIAL PARK
caesarea,  IL 38900
Applicant Contact shlomi dines
Correspondent
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
INDUSTRIAL PARK
caesarea,  IL 38900
Correspondent Contact shlomi dines
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/14/2007
Decision Date 04/13/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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