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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K891077
Device Name MEDIVERSE PARENTERAL NUTRITION BAG
Applicant
Mediflex Intl.
45 Kulick Rd.
Fairfield,  NJ  07006
Applicant Contact UDINE
Correspondent
Mediflex Intl.
45 Kulick Rd.
Fairfield,  NJ  07006
Correspondent Contact UDINE
Regulation Number880.5025
Classification Product Code
KPE  
Date Received03/01/1989
Decision Date 05/24/1989
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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