• 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 component, cast
510(k) Number K823394
Device Name WALKING HEEL
Applicant
ORTHOPEDIC SYSTEMS, INC.
803 n. front st. suite 3
mchenry,  IL  60050
Correspondent
ORTHOPEDIC SYSTEMS, INC.
803 n. front st. suite 3
mchenry,  IL  60050
Regulation Number888.5940
Classification Product Code
LGF  
Date Received11/12/1982
Decision Date 12/03/1982
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-