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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K111016
Device Name SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
Applicant
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Applicant Contact NATASHA EVRONYAN
Correspondent
Elcam Medical Acal
Kibbutz Bar-Am
Mp. Merom Hagalil,  IL 13860
Correspondent Contact NATASHA EVRONYAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/12/2011
Decision Date 06/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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