FDA 510(k) Application Details - K042527

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K042527
Device Name	Spatula, Cervical, Cytological
Applicant	MEDICAL ACTION INDUSTRIES, INC. 25 HEYWOOD RD. ARDEN, NC 28704 US Other 510(k) Applications for this Company
Contact	ROBIN BLANKENBAKER 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	09/17/2004
Decision Date	11/08/2004
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