FDA 510(k) Application Details - DEN060003

Device Classification Name	Suture, Recombinant Technology   More FDA Info for this Device
510(K) Number	DEN060003
Device Name	Suture, Recombinant Technology
Applicant	TEPHA, INC. 840 MEMORIAL DRIVE CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	MARY P LEGRAW Other 510(k) Applications for this Contact
Regulation Number	878.4494   More FDA Info for this Regulation Number
Classification Product Code	NWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2006
Decision Date	02/08/2007
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review