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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 K171796
Device Name Vial Adapter 15mm
Applicant
Medimop Medical Project , Ltd.
17 Hatidhar St.
Ra'Anana,  IL 43665
Applicant Contact Jeffrey Ravel
Correspondent
Medimop Medical Project , Ltd.
17 Hatidhar St.
Ra'Anana,  IL 43665
Correspondent Contact Jeffrey Ravel
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/16/2017
Decision Date 10/12/2017
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
Predetermined Change
Control Plan Authorized		 No
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