• 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 equipment, traction, powered
510(k) Number K881603
Device Name ULTRA TRACTION
Applicant
COMPONENT EQUIPMENT MFG., INC.
615 CONRAD ST.
colorado springs,  CO  80915
Applicant Contact timothy j junk
Correspondent
COMPONENT EQUIPMENT MFG., INC.
615 CONRAD ST.
colorado springs,  CO  80915
Correspondent Contact timothy j junk
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/13/1988
Decision Date 05/04/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-