FDA 510(k) Application Details - K081099

Device Classification Name	Suture, Recombinant Technology   More FDA Info for this Device
510(K) Number	K081099
Device Name	Suture, Recombinant Technology
Applicant	TEPHA, INC. 99 HAYDEN, SUTIE 360 LEXINGTON, MA 02421 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	04/17/2008
Decision Date	07/15/2008
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