• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name powered laser surgical instrument
510(k) Number K121938
Device Name MEDILAS H RFID LASER FIBER
Original Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw,  GA  30144
Original Contact john hoffer
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/02/2012
Decision Date 08/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-