FDA 510(k) Application Details - K141637

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K141637
Device Name	Dressing, Wound, Drug
Applicant	BIOTD, S.A. 816 CONGRESS AVENUE - STE 1400 AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	RICHARD GILLIS, PH.D. Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2014
Decision Date	06/03/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review