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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 K072511
Device Name SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
Applicant
Medimop Medical Projects, Ltd.
101 Gordon Dr.
Lionville,  PA  19341
Applicant Contact ARI Y SOBEL
Correspondent
Medimop Medical Projects, Ltd.
101 Gordon Dr.
Lionville,  PA  19341
Correspondent Contact ARI Y SOBEL
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/06/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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