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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K140730
Device Name VIAL2BAG DIRECT CONNECT
Applicant
Medimop Medical Projects, Ltd.
17 Hatidhar St.
Ra'Anana,  IL 4366519
Applicant Contact ILANIT GOLDGRABER
Correspondent
Medimop Medical Projects, Ltd.
17 Hatidhar St.
Ra'Anana,  IL 4366519
Correspondent Contact ILANIT GOLDGRABER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/24/2014
Decision Date 06/12/2014
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
Recalls CDRH Recalls
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