FDA 510(k) Application Details - K971586

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K971586
Device Name	Spatula, Cervical, Cytological
Applicant	DIGENE CORP. 9000 VIRGINIA MANOR RD., BELTSVILLE, MD 20705 US Other 510(k) Applications for this Company
Contact	CONSTANCE A FINCH 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	05/01/1997
Decision Date	09/19/1997
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