FDA 510(k) Application Details - K991595

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K991595
Device Name	Spatula, Cervical, Cytological
Applicant	ORIFICE MEDICAL AB BRONSGATAN 12 YSTAD S-271 39 SE Other 510(k) Applications for this Company
Contact	PATRIC NILSSON 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	05/07/1999
Decision Date	06/29/1999
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