Device Classification Name |
System, Applicator, Radionuclide, Remote-Controlled
|
510(k) Number |
K142330 |
Device Name |
Kobold Ring and Tandem Applicator Set |
Applicant |
KOBOLD, LLC |
23403 E Mission Ave, Ste 220E |
Liberty Lake,
WA
99019
|
|
Applicant Contact |
Spencer Fillmore |
Correspondent |
KOBOLD, LLC |
23403 E Mission Ave, Ste 220E |
Liberty Lake,
WA
99019
|
|
Correspondent Contact |
Spencer Fillmore |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 08/20/2014 |
Decision Date | 04/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|