FDA 510(k) Application Details - K002830

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K002830
Device Name	Perineometer
Applicant	COLONIAL MEDICAL SUPPLY 1350 E. FLAMINGO RD. # 343 LAS VEGAS, NV 89119 US Other 510(k) Applications for this Company
Contact	PATRICIA LEIGH, R.N. 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	09/11/2000
Decision Date	12/27/2000
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