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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 K933898
Device Name HUBER NEEDLE SETS
Applicant
Mediziv Medical Products 1987 , Ltd.
88 Weizman St.
Tel Aviv,  IL 62264
Applicant Contact MIRI SANI
Correspondent
Mediziv Medical Products 1987 , Ltd.
88 Weizman St.
Tel Aviv,  IL 62264
Correspondent Contact MIRI SANI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/10/1993
Decision Date 09/27/1995
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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