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 System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K130757
Device Name KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
Applicant
Spencer Fillmore
2670 Leavenworth St.
San Francisco,  CA  94133
Applicant Contact CHRISTINA BERNSTEIN
Correspondent
Spencer Fillmore
2670 Leavenworth St.
San Francisco,  CA  94133
Correspondent Contact CHRISTINA BERNSTEIN
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/20/2013
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-