FDA 510(k) Application Details - K043369

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K043369
Device Name	Spatula, Cervical, Cytological
Applicant	ROVERS MEDICAL DEVICES B.V. LEKSTRAAT 10 OSS 5347 KV NL Other 510(k) Applications for this Company
Contact	IR. M.D. ZWART 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	12/08/2004
Decision Date	02/02/2005
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