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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 K963583
Device Name MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
Applicant
Medimop Medical Projects, Ltd.
4 Mayezira St.
P.O.Box 2499
Raanana,  IL 43000
Applicant Contact FREDDY ZINGER
Correspondent
Medimop Medical Projects, Ltd.
4 Mayezira St.
P.O.Box 2499
Raanana,  IL 43000
Correspondent Contact FREDDY ZINGER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/06/1996
Decision Date 10/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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