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 Sling, Arm, Overhead Supported
510(k) Number K823811
Device Name OVERHEAD ARM SLINGS
Applicant
DANEK MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DANEK MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3475
Classification Product Code
ILE  
Date Received12/17/1982
Decision Date 01/14/1983
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
-
-