MICK RADIO / In Vitro Diagnostics / Christine Bernstein Regulatory Director BB Medical Surgical Inc. / KOBOLD LLC / SUBSTANTIAL KoBOLD LLC / Christina Bernstein BB Medical Surgical Inc. / /
Event
M&A / FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
tumor site / announcements concerning your device / predicate devices / tumtor site / treatment of cancer / appropriate afierloader systems / predicate device / fundamental technology / manufacturing practice requirements / non-invasive products / tumnor site / marketed predicate devices / manufacturing practice / tumior site / tumor'site / noninvasive products / Internet address http /
Radiological Health Office / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / CDRH 's office of Surveillance / FDA / Public Health Service / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Drug Administration / /
Person
Janine M. Morris / Lane Greenacres / Spencer Fillmore / / /
K130757 Kobold SecureLock -Transfer Guide Tube Set, Kobold I nterstitial Extender Set APR[removed]k) Summary This summary of 510(k) safety and effectiveness in formation is furnished in accordance with requirements