FDA 510(k) Application Details - K992537

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K992537
Device Name	Mesh, Surgical
Applicant	BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. ST. PAUL, MN 55114-1024 US Other 510(k) Applications for this Company
Contact	MARY KAY KESSINGER SOBCINSKI Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/1999
Decision Date	02/22/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review