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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K933523
Device Name I.V. FILTER SET
Applicant
Mediziv Medical Products 1987 , Ltd.
88 Weizman St.
Tel Aviv,  IL 62264
Applicant Contact MURI SANI
Correspondent
Mediziv Medical Products 1987 , Ltd.
88 Weizman St.
Tel Aviv,  IL 62264
Correspondent Contact MURI SANI
Regulation Number880.5440
Classification Product Code
FPB  
Date Received07/20/1993
Decision Date 05/19/1995
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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