FDA 510(k) Application Details - K955072

Device Classification Name	Dilator, Cervical, Hygroscopic-Laminaria   More FDA Info for this Device
510(K) Number	K955072
Device Name	Dilator, Cervical, Hygroscopic-Laminaria
Applicant	CTI CORP., LTD. 607 ELMIRA RD. VACAVILLE, CA 95687 US Other 510(k) Applications for this Company
Contact	OSCAR PELAEZ TAN 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	11/06/1995
Decision Date	05/22/1996
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