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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 K963889
Device Name QFC UMBILICAL CLAMP
Applicant
Qfc Industries
2405 Forest Park Blvd.
Fort Worth,  TX  76110 -1765
Applicant Contact GLENN CRUM
Correspondent
Qfc Industries
2405 Forest Park Blvd.
Fort Worth,  TX  76110 -1765
Correspondent Contact GLENN CRUM
Regulation Number884.4530
Classification Product Code
HFW  
Date Received09/26/1996
Decision Date 04/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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