FDA 510(k) Application Details - K011512

Device Classification Name	Dilator, Cervical, Hygroscopic-Laminaria   More FDA Info for this Device
510(K) Number	K011512
Device Name	Dilator, Cervical, Hygroscopic-Laminaria
Applicant	A & A MEDICAL, INC. 9370 INDUSTRIAL TRACE ALPHARETTA, GA 30004-3383 US Other 510(k) Applications for this Company
Contact	JIHAD (JAY) MANSOUR 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	05/16/2001
Decision Date	07/09/2001
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