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 Parathyroid Autofluorescence Imaging Device
510(k) Number K190891
Device Name Fluobeam LX
Applicant
Fluoptics
7 Parvis Louis Neel, Cs 20050
Grenoble Cedex 9,  FR
Applicant Contact Odile Allard
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gerdnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number878.4550
Classification Product Code
QDG  
Date Received04/05/2019
Decision Date 07/31/2019
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 Yes
Predetermined Change
Control Plan Authorized		 No
-
-