FDA 510(k) Application Details - K963580

Device Classification Name	Falloposcope   More FDA Info for this Device
510(K) Number	K963580
Device Name	Falloposcope
Applicant	IMAGYN MEDICAL, INC. 27651 LA PAZ RD. LAGUNA NIGUEL, CA 92656-3917 US Other 510(k) Applications for this Company
Contact	DEBRA A RINDERER 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	09/06/1996
Decision Date	01/31/1997
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