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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 K001293
Device Name MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
Applicant
Medimop Medical Projects, Ltd.
815 Connection Ave., NW
Washington,  DC  20006
Applicant Contact BRUCE F MACKLER
Correspondent
Medimop Medical Projects, Ltd.
815 Connection Ave., NW
Washington,  DC  20006
Correspondent Contact BRUCE F MACKLER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/24/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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