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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 K061325
Device Name BODYGAURD PAIN MANAGER INFUSION SYSTEM
Applicant
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Caesarea Industrial Park
Caesarea,  IL 38900
Applicant Contact SHLOMI DINES
Correspondent
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Caesarea Industrial Park
Caesarea,  IL 38900
Correspondent Contact SHLOMI DINES
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/11/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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