FDA 510(k) Application Details - K001119

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K001119
Device Name	Spatula, Cervical, Cytological
Applicant	ROVERS MEDICAL DEVICES B.V. 960 CHAPEA RD. PASADENA, CA 91107 US Other 510(k) Applications for this Company
Contact	TODD M GATES 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	04/07/2000
Decision Date	05/19/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review