FDA 510(k) Application Details - K062563

Device Classification Name	Tenaculum, Uterine   More FDA Info for this Device
510(K) Number	K062563
Device Name	Tenaculum, Uterine
Applicant	FEM SUITE, L.L.C. 1530 HOLCOMB STREET PORT TOWNSEND, WA 98368 US Other 510(k) Applications for this Company
Contact	CARL YOUNGMANN Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2006
Decision Date	05/18/2007
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