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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 K080954
Device Name T34L SYRINGE DRIVER
Applicant
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Industrial Park
Caesarea,  IL 38900
Applicant Contact EVA PARTAS
Correspondent
Caesarea Medical Electronics , Ltd.
16 Shacham St.
Industrial Park
Caesarea,  IL 38900
Correspondent Contact EVA PARTAS
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MEA  
Date Received04/03/2008
Decision Date 05/16/2008
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
Recalls CDRH Recalls
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