FDA 510(k) Application Details - K981277

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K981277
Device Name	Perineometer
Applicant	VERIMED HOLDINGS, INC. 11950 N.W. 39TH ST., SUITE D CORAL SPRINGS, FL 33065 US Other 510(k) Applications for this Company
Contact	KISHORE PUPPALA 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	04/08/1998
Decision Date	11/20/1998
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