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FDA 510(k) Application Details - K963889
Device Classification Name
Clamp, Umbilical
More FDA Info for this Device
510(K) Number
K963889
Device Name
Clamp, Umbilical
Applicant
QFC INDUSTRIES
2405 FOREST PARK BLVD.
FORT WORTH, TX 76110-1765 US
Other 510(k) Applications for this Company
Contact
GLENN CRUM
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HFW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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