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 K190689
Device Name SignalMark Breast Marker
Applicant
View Point Medical, Inc.
5621 Palmer Way, Suite F
Carlsbad,  CA  92010
Applicant Contact Thomas Kane
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Michelle Rubin-Onur
Regulation Number878.4300
Classification Product Code
NEU  
Subsequent Product Code
GDW  
Date Received03/18/2019
Decision Date 08/14/2019
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 No
Predetermined Change
Control Plan Authorized		 No
-
-