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 Orthosis, Limb Brace
510(k) Number K811343
Device Name HUMERAL FRACTURE CAST BRACE
Applicant
DESERET MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DESERET MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3475
Classification Product Code
IQI  
Date Received05/12/1981
Decision Date 05/28/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-