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 K093473
Device Name KMD-MARK1 TISSUE MARKER
Applicant
Kent Medical Devices, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Kent Medical Devices, Inc.
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number878.4300
Classification Product Code
NEU  
Date Received11/06/2009
Decision Date 07/02/2010
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 Yes
Predetermined Change
Control Plan Authorized		 No
-
-