FDA 510(k) Application Details - K954311

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K954311
Device Name	Culdoscope (And Accessories)
Applicant	COOPERSURGICAL, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY M MCNAMARA 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	09/15/1995
Decision Date	11/19/1996
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