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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 A.C.A.L.
KIBBUTZ BAR-AM
D.N. MEROM HAGALIL,  IL 13860
Applicant Contact NATASHA EVRONYAN
Correspondent
ELCAM MEDICAL A.C.A.L.
KIBBUTZ BAR-AM
D.N. 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
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