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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 K050800
Device Name NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
P.O.B. 4294
CAESAREA,  IL 38900
Applicant Contact GALI TZURY
Correspondent
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
P.O.B. 4294
CAESAREA,  IL 38900
Correspondent Contact GALI TZURY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/30/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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