• 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 arthrometer
510(k) Number K834462
Device Name GENUCOM
Applicant
FAR ORTHOPEDICS, INC.
MD 
Correspondent
FAR ORTHOPEDICS, INC.
MD 
Regulation Number890.1615
Classification Product Code
LYH  
Date Received12/19/1983
Decision Date 02/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-