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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K053405
Device Name BACSTOP
Applicant
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Applicant Contact TALI HAZAN
Correspondent
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Correspondent Contact TALI HAZAN
Regulation Number880.5440
Classification Product Code
FMG  
Date Received12/07/2005
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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