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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K884491
Device Name MEDIZIV CENTRAL VEIN CATHETER
Applicant
MEDIZIV MEDICAL DEVICES, LTD.
88, WEIZMAN ST.
TEL-AVIV 62264
ISRAEL,  IL
Applicant Contact SHMUEL BAR-ZIV
Correspondent
MEDIZIV MEDICAL DEVICES, LTD.
88, WEIZMAN ST.
TEL-AVIV 62264
ISRAEL,  IL
Correspondent Contact SHMUEL BAR-ZIV
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/26/1988
Decision Date 06/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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