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 Joint, Elbow, External Limb Component, Powered
510(k) Number K802642
Device Name UTAH ARTIFICAL ARM
Applicant
Motion Control, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Motion Control, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3420
Classification Product Code
IRE  
Date Received10/24/1980
Decision Date 11/12/1980
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
-
-