FDA 510(k) Application Details - K052314

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K052314
Device Name	Speculum, Vaginal, Nonmetal
Applicant	DYNAREX CORP. 10 GLENSHAW ST. ORANGEBURG, NY 10962 US Other 510(k) Applications for this Company
Contact	JAMES HURLMAN 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	08/25/2005
Decision Date	11/09/2005
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