FDA 510(k) Application Details - K000227

Device Classification Name	Clamp, Umbilical   More FDA Info for this Device
510(K) Number	K000227
Device Name	Clamp, Umbilical
Applicant	POLLAK (INTL.), LTD. HAMLACHA 20, INDUSTRIAL ZONE ROSH HA'AYIN 48091 IL Other 510(k) Applications for this Company
Contact	MICHAEL PORAT 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	01/24/2000
Decision Date	04/27/2000
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