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 Bedding, Disposable, Medical
510(k) Number K821835
Device Name BARRIER BURN SHEET
Applicant
Uhi Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Uhi Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6060
Classification Product Code
KME  
Date Received06/22/1982
Decision Date 07/02/1982
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
-
-