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 K143484
Device Name BioZorb Marker
Applicant
FOCAL THERAPEUTICS
4370 ALPINE RD. #101
PORTOLA VALLEY,  CA  94028
Applicant Contact George Hermann
Correspondent
FOCAL THERAPEUTICS
4370 ALPINE RD. #101
PORTOLA VALLEY,  CA  94028
Correspondent Contact George Hermann
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/08/2014
Decision Date 06/29/2015
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
Recalls CDRH Recalls
-
-