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 Staple, Implantable
510(k) Number K000060
Device Name GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
Applicant
Senorx, Inc.
13766 Alton Pkwy.
Suite 144
Irvine,  CA  92677
Applicant Contact AMY BOUCLY
Correspondent
Senorx, Inc.
13766 Alton Pkwy.
Suite 144
Irvine,  CA  92677
Correspondent Contact AMY BOUCLY
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
FZP  
Date Received01/10/2000
Decision Date 03/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-