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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K000227
Device Name UMBICUT
Applicant
POLLAK (INTL.), LTD.
HAMLACHA 20, INDUSTRIAL ZONE
ROSH HA'AYIN,  IL 48091
Applicant Contact MICHAEL PORAT
Correspondent
POLLAK (INTL.), LTD.
HAMLACHA 20, INDUSTRIAL ZONE
ROSH HA'AYIN,  IL 48091
Correspondent Contact MICHAEL PORAT
Regulation Number884.4530
Classification Product Code
HFW  
Subsequent Product Code
HDJ  
Date Received01/24/2000
Decision Date 04/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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