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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 K060231
Device Name CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
Applicant
ELCAM MEDICAL A.C.A.L.
KIBBUTZ BAR-AM
D.N. MEROM HAGALIL,  IL 13860
Applicant Contact TALI HAZAN
Correspondent
ELCAM MEDICAL A.C.A.L.
KIBBUTZ BAR-AM
D.N. MEROM HAGALIL,  IL 13860
Correspondent Contact TALI HAZAN
Regulation Number880.5440
Classification Product Code
FMG  
Date Received01/30/2006
Decision Date 04/13/2006
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
Recalls CDRH Recalls
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