FDA 510(k) Application Details - K040625

Device Classification Name	Dilator, Cervical, Hygroscopic-Laminaria   More FDA Info for this Device
510(K) Number	K040625
Device Name	Dilator, Cervical, Hygroscopic-Laminaria
Applicant	ATAD DEVELOPMENTS LTD. 70 YAKINTON ST. RAMAT ALMOGI HAIFA 34792 IL Other 510(k) Applications for this Company
Contact	JACK ATAD Other 510(k) Applications for this Contact
Regulation Number	884.4260   More FDA Info for this Regulation Number
Classification Product Code	HDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2004
Decision Date	01/18/2005
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