FDA 510(k) Application Details - K012917

Device Classification Name	Clamp, Umbilical   More FDA Info for this Device
510(K) Number	K012917
Device Name	Clamp, Umbilical
Applicant	DYNAREX CORP. 7736 WOODSIDE COURT MAINEVILLE, OH 45039 US Other 510(k) Applications for this Company
Contact	JOHN GAGLIARDI 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	08/30/2001
Decision Date	11/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review