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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 K170095
Device Name Vial2Bag Direct Connect
Applicant
Medimop Medical Project Ltd.
17 Hatidhar St.
Ra'anana,  IL 43665
Applicant Contact Ilanit Goldgraber
Correspondent
Medimop Medical Project Ltd.
17 Hatidhar St.
Ra'anana,  IL 43665
Correspondent Contact Ilanit Goldgraber
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/11/2017
Decision Date 03/08/2017
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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