FDA 510(k) Application Details - K021115

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K021115
Device Name	Perineometer
Applicant	NAISSANCE HOLDINGS, LC 800 CONNECTICUT AVENUE, N.W. SUITE 500 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	NANCY E TAYLOR Other 510(k) Applications for this Contact
Regulation Number	884.1425   More FDA Info for this Regulation Number
Classification Product Code	HIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2002
Decision Date	12/20/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review