FDA 510(k) Application Details - K991296

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K991296
Device Name	Mesh, Surgical
Applicant	TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING ALACHUA, FL 32615 US Other 510(k) Applications for this Company
Contact	PJ PARDO 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	04/15/1999
Decision Date	10/06/2000
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