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 K832483
Device Name MATTRESS COVER, ANTI-MICROBIAL
Applicant
American Threshold Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Threshold Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6190
Classification Product Code
FMW  
Date Received07/25/1983
Decision Date 02/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-