FDA 510(k) Application Details - K994263

Device Classification Name	Clamp, Umbilical   More FDA Info for this Device
510(K) Number	K994263
Device Name	Clamp, Umbilical
Applicant	PRECISION DYNAMICS CORP. 13880 DEL SUR ST. SAN FERNANDO, CA 91340-3490 US Other 510(k) Applications for this Company
Contact	KALYNA SNYLYK 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	12/17/1999
Decision Date	01/24/2000
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