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 laser surgical instrument
510(k) Number K103288
Device Name DEKA SYNCHRO FT
Applicant
EL.EN. ELECTRONIC ENGINEERING SPA
17 VIA BALDANZESE
CALENZANO,  IT 50041
Applicant Contact PAOLO PERUZZI
Correspondent
EL.EN. ELECTRONIC ENGINEERING SPA
17 VIA BALDANZESE
CALENZANO,  IT 50041
Correspondent Contact PAOLO PERUZZI
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received11/08/2010
Decision Date 01/31/2011
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
-
-