FDA 510(k) Applications for Medical Device Product Code "FMW"
(Cover, Mattress (Medical Purposes))

FDA 510(k) Number Applicant Device Name Decision Date
K992702 ALLERGY DIRECT EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM 11/08/1999
K001003 DEMITE LIMITED Z-NET 12/10/2001
K152884 PRECISION FABRICS GROUP, INC. DermaTherapy Bed Linens 06/20/2016
K061242 PRECISION FABRICS GROUP, INC. DERMATHERAPY, MODEL 22216 01/25/2007


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