FDA 510(k) Application Details - K992655

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K992655
Device Name	Culdoscope (And Accessories)
Applicant	SOPRANE S.A. 555 THIRTEENTH ST., N.W. WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	884.1640   More FDA Info for this Regulation Number
Classification Product Code	HEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/1999
Decision Date	03/13/2000
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