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510(k) K152884

Device
DermaTherapy Bed Linens
Applicant
PRECISION FABRICS GROUP, INC.
510(k) number
K152884
Product code
FMW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-20
Date received
2015-09-30
Regulation
880.6190
Classification name
Cover, Mattress (medical Purposes)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Terry Montgomery
Address
301 N. Elm St., Suite 600 Greensboro NC US 27401 27401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061242DERMATHERAPY, MODEL 22216Precision Fabrics Group, Inc.2007-01-25
K001003Z-NETDemite Limited2001-12-10
K992702EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEMAllergy Direct1999-11-08
K940327INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOWW. L. Gore & Associates, Inc.1994-02-25
K935220CORE PREVENT MATTRESS MODIFICATIONPaladin Medical, Inc.1993-11-29
K924807REUSABLE INCONTIENT UNDERPADPerfect Fit Industries, Inc.1993-02-10
K924477WIPEABLE PILLOWPerfect Fit Industries, Inc.1993-01-29
K921928SOFT-COVERAdroit Medical Systems, Inc.1992-11-06
K923173OBALON COVERTurnsoft, Inc.1992-11-06
K903382ALLERGY CONTROL COVERSAllergy Control Products, Inc.1990-11-02
K902446DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUSTMallinckrodt Group, Inc.1990-08-10
K832483MATTRESS COVER, ANTI-MICROBIALAmerican Threshold Industries, Inc.1984-02-04
K780033MATTRESSES, CONDUCTIVE & COVERSChase Mfg. Co.1978-02-21

Legacy Summary#

summary

FDA Review#

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