Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Cover, Mattress (Medical Purposes)
510(k) Number K152884
Device Name DermaTherapy Bed Linens
Applicant
Precision Fabrics Group, Inc.
301 N. Elm St., Suite 600
Greensboro,  NC  27401
Applicant Contact Terry Montgomery
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number880.6190
Classification Product Code
FMW  
Date Received09/30/2015
Decision Date 06/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-