FDA 510(k) Application Details - K101128

Device Classification Name	More FDA Info for this Device
510(K) Number	K101128
Device Name	BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Applicant	FILLIGENT LIMITED 611 WEST 5TH STREET THIRD FLOOR AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	IAN GORDON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2010
Decision Date	05/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review