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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 K994367
Device Name UMBILICAL CORD CLAMP
Applicant
MEDICAL SALES CO.
P.O. BOX 540314
101 N. 700 WEST
NORTH SALT LAKE,  UT  84054
Applicant Contact JOHN E LINCOLN
Correspondent
MEDICAL SALES CO.
P.O. BOX 540314
101 N. 700 WEST
NORTH SALT LAKE,  UT  84054
Correspondent Contact JOHN E LINCOLN
Regulation Number884.4530
Classification Product Code
HFW  
Date Received12/27/1999
Decision Date 03/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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