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 Marker, Radiographic, Implantable
510(k) Number K180443
Device Name Tumark Vision
Applicant
Somatex Medical Technologies GmbH
Rheinstr. 7d
Teltow,  DE 14513
Applicant Contact Burkhard Jakob
Correspondent
Somatex Medical Technologies GmbH
Rheinstr. 7d
Teltow,  DE 14513
Correspondent Contact Burkhard Jakob
Regulation Number878.4300
Classification Product Code
NEU  
Date Received02/20/2018
Decision Date 03/22/2018
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
Predetermined Change
Control Plan Authorized		 No
-
-