FDA 510(k) Application Details - K120743

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K120743
Device Name	Speculum, Vaginal, Nonmetal
Applicant	WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS, NY 13153-0220 US Other 510(k) Applications for this Company
Contact	KEVIN CROSSEN Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2012
Decision Date	03/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review