FDA 510(k) Application Details - K081522

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K081522
Device Name	Spatula, Cervical, Cytological
Applicant	BIO NUCLEAR DIAGNOSTICS, INC. 1791 ALBION RD. TORONTO, ONTARIO M9W 5S7 CA Other 510(k) Applications for this Company
Contact	SURENDER CHOUDHRY Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2008
Decision Date	12/05/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review