FDA 510(k) Application Details - K061339

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K061339
Device Name	Speculum, Vaginal, Nonmetal
Applicant	MEDICAL PRODUCTS DIV. 2410 EXECUTIVE DRIVE INDIANAPOLIS, IN 46241 US Other 510(k) Applications for this Company
Contact	THOMAS W COPELAND 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	05/15/2006
Decision Date	09/19/2006
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