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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 K983204
Device Name HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
Applicant
HARWILL MEDICAL (PTY) LTD.
P O BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
HARWILL MEDICAL (PTY) LTD.
P O BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.4530
Classification Product Code
HFW  
Date Received09/14/1998
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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