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 K251748
Device Name MammoSTAR Biopsy Site Identifier
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact Yidi Hou
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact Yidi Hou
Regulation Number878.4300
Classification Product Code
NEU  
Date Received06/06/2025
Decision Date 07/23/2025
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
-
-