FDA 510(k) Application Details - K161092

Device Classification Name	Surgical Film   More FDA Info for this Device
510(K) Number	K161092
Device Name	Surgical Film
Applicant	Tepha, Inc. 99 Hayden Avenue Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Connie H Garrison Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	OOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2016
Decision Date	08/23/2016
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