FDA 510(k), K122702, BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR

510(K) Number: K122702
Device Name: BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Manufacturer: FILLIGENT LIMITED
Device Classification Name: N95 Respirator With Antimicrobial/Antiviral Agent
Regulation Number: 878.4040
Classification Product Code: ONT
Date Received: 09/04/2012
Decision Date: 03/18/2013
Regulation Medical Specialty: General & Plastic Surgery

555 pages (1,280 of 1,835 pages are fully redacted)