FDA 510(k) Application Details - K202425

Device Classification Name	Surgical Film   More FDA Info for this Device
510(K) Number	K202425
Device Name	Surgical Film
Applicant	Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Kavetha Ram 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	08/25/2020
Decision Date	08/19/2021
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