FDA 510(k) Application Details - K980431

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K980431
Device Name	Mesh, Surgical
Applicant	COOK BIOTECH, INC. P.O. BOX 2603, 3055 KENT AVE. WEST LAFAYETTE, IN 47906 US Other 510(k) Applications for this Company
Contact	NEAL E FEARNOTM PH.D 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	02/04/1998
Decision Date	05/28/1998
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