FDA 510(k) Application Details - K063223

Device Classification Name	Diaphragm, Contraceptive (And Accessories)   More FDA Info for this Device
510(K) Number	K063223
Device Name	Diaphragm, Contraceptive (And Accessories)
Applicant	COOPERSURGICAL, INC. 543 LONG HILL AVE. SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH AZARY Other 510(k) Applications for this Contact
Regulation Number	884.5350   More FDA Info for this Regulation Number
Classification Product Code	HDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2006
Decision Date	01/23/2008
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