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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 K852106
Device Name I.V. ADMINISTRATION SET
Applicant
Mediflex Intl.
45 Kulick Rd.
Fairfield,  NJ  07006
Applicant Contact EDGAR UDINE
Correspondent
Mediflex Intl.
45 Kulick Rd.
Fairfield,  NJ  07006
Correspondent Contact EDGAR UDINE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/15/1985
Decision Date 06/07/1985
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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