FDA 510(k) Application Details - K013289

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K013289
Device Name	Pessary, Vaginal
Applicant	BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C LANGHORNE, PA 19047 US Other 510(k) Applications for this Company
Contact	DENIS DORSEY Other 510(k) Applications for this Contact
Regulation Number	884.3575   More FDA Info for this Regulation Number
Classification Product Code	HHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2001
Decision Date	12/27/2001
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