FDA 510(k) Application Details - K963889

Device Classification Name Clamp, Umbilical

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510(K) Number K963889
Device Name Clamp, Umbilical
Applicant QFC INDUSTRIES
2405 FOREST PARK BLVD.
FORT WORTH, TX 76110-1765 US
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Contact GLENN CRUM
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Regulation Number 884.4530

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Classification Product Code HFW
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Date Received 09/26/1996
Decision Date 04/18/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K963889


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