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 Powered Light Based Non-Laser Surgical Instrument
510(k) Number K100628
Device Name PLASMALUXLS
Applicant
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Applicant Contact MICHELE THIEL
Correspondent
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Correspondent Contact MICHELE THIEL
Regulation Number878.4810
Classification Product Code
ONE  
Date Received03/05/2010
Decision Date 11/24/2010
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
Predetermined Change
Control Plan Authorized		 No
-
-