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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 AVENUE, N.W.
WASHINGTON,  DC  20006 -4004
Applicant Contact BRUCE F MACKLER
Correspondent
MEDIMOP MEDICAL PROJECTS, LTD.
815 CONNECTION AVENUE, N.W.
WASHINGTON,  DC  20006 -4004
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
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