FDA 510(k) Application Details - K132348

Device Classification Name	Suture, Recombinant Technology   More FDA Info for this Device
510(K) Number	K132348
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	07/29/2013
Decision Date	09/05/2013
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