• 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 light, surgical, accessories
510(k) Number K142386
Device Name Operating Room Light Handle Adapter
Litex Manufacturing, Inc.
1501 Sunshine Drive
Glendale,  CA  91208
Applicant Contact Noel Gharibian
8741 Shirley Ave
Northridge,  CA  91324
Correspondent Contact MIKE HOFTMAN
Regulation Number878.4580
Classification Product Code
Date Received08/27/2014
Decision Date 09/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No