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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 K911128
Device Name MEDIZIV INFUSION SET
Applicant
Medicia Medical Products
88, Weizman St.
Tel-Aviv 62264 Israel,  IL
Applicant Contact BEN-ZION SHABTAI
Correspondent
Medicia Medical Products
88, Weizman St.
Tel-Aviv 62264 Israel,  IL
Correspondent Contact BEN-ZION SHABTAI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/14/1991
Decision Date 09/06/1991
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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