FDA 510(k) Application Details - K023305

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K023305
Device Name	Perineometer
Applicant	KEGELMASTER 2000 LTD. P.O. BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLANDA SMITH 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	10/03/2002
Decision Date	12/26/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review