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 Light, Surgical, Floor Standing
510(k) Number K091246
Device Name ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
Applicant
Trumpf Medizin Systeme GmbH + Co. KG
415 Jessen Ln.
Charleston,  SC  29492
Applicant Contact LINDSEY HENGEL
Correspondent
Trumpf Medizin Systeme GmbH + Co. KG
415 Jessen Ln.
Charleston,  SC  29492
Correspondent Contact LINDSEY HENGEL
Regulation Number878.4580
Classification Product Code
FSS  
Date Received04/27/2009
Decision Date 09/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-