FDA 510(k) Application Details - K003540

Device Classification Name	Speculum, Vaginal, Nonmetal   More FDA Info for this Device
510(K) Number	K003540
Device Name	Speculum, Vaginal, Nonmetal
Applicant	FEMINICA, INC. 3216 MONSABRE MONTREAL, QUEBEC H1N 2L5 CA Other 510(k) Applications for this Company
Contact	DENIS H DUBOIS 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	11/16/2000
Decision Date	02/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review