FDA 510(k) Application Details - K954903

Device Classification Name	Aspirator, Endocervical   More FDA Info for this Device
510(K) Number	K954903
Device Name	Aspirator, Endocervical
Applicant	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	TAMMY BACON Other 510(k) Applications for this Contact
Regulation Number	884.1050   More FDA Info for this Regulation Number
Classification Product Code	HFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/1995
Decision Date	04/29/1996
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