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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 K031861
FOIA Releasable 510(k) K031861
Device Name MIX2VIAL TRANSFER DEVICE
Applicant
Medimop Medical Projects, Ltd.
Mitzpe Aviv, Industrial Pk 13
M.P. Misgav,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Medimop Medical Projects, Ltd.
Mitzpe Aviv, Industrial Pk 13
M.P. Misgav,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/16/2003
Decision Date 07/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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