FDA 510(k) Application Details - K011840

Device Classification Name	Sound, Uterine   More FDA Info for this Device
510(K) Number	K011840
Device Name	Sound, Uterine
Applicant	CERVILENZ INC 2 DELPHINUS IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	JUDY F GORDON Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2001
Decision Date	08/10/2001
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