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510(k) K101128

Device
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Applicant
FILLIGENT LIMITED
510(k) number
K101128
Product code
OUK  
Decision
Substantially Equivalent (SESE)
Decision date
2011-05-26
Date received
2010-04-22
Regulation
878.4040
Classification name
Surgical Mask With Antimicrobial/antiviral Agent
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
IAN GORDON
Address
611 W. 5th St. Third Floor Austin TX US 78701 78701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231741ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige Ameritech2024-09-05
K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited2019-11-29
K182766Cufitec Surgical MaskNbc Meshtec, Inc.2019-01-03

Legacy Summary#

summary

FDA Review#

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