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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 K070235
Device Name BODYGUARD PAIN MANAGER INFUSION SYSTEM
Applicant
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Industrial Park
Caesarea,  IL 38900
Applicant Contact SHLOMI DINES
Correspondent
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Industrial Park
Caesarea,  IL 38900
Correspondent Contact SHLOMI DINES
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/25/2007
Decision Date 05/18/2007
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
Predetermined Change
Control Plan Authorized		 No
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