FDA 510(k) Application Details - K974028

Device Classification Name	Falloposcope   More FDA Info for this Device
510(K) Number	K974028
Device Name	Falloposcope
Applicant	CONCEPTUS, INC. 1021 HOWARD AVE. SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	CONNIE ACUFF Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1997
Decision Date	01/21/1998
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