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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K861250
Device Name MESULIN, INSULIN INFUSION SET
Applicant
Molnlycke A/S Hospital Products
Hoejvangen 6,
Dk-3060 Espergaerde
Denmark,  DK
Applicant Contact BENTE LEWINSKY
Correspondent
Molnlycke A/S Hospital Products
Hoejvangen 6,
Dk-3060 Espergaerde
Denmark,  DK
Correspondent Contact BENTE LEWINSKY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/02/1986
Decision Date 05/23/1986
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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