Device Classification Name |
light source, fiberoptic, routine
|
510(k) Number |
K093792 |
Device Name |
LED LIGHT SOURCE |
Applicant |
SUNOPTIC TECHNOLOGIES, LLC |
6018 BOWDENDALE AVE. |
JACKSONVILLE,
FL
32216 -6042
|
|
Applicant Contact |
JANICE G LEE |
Correspondent |
SUNOPTIC TECHNOLOGIES, LLC |
6018 BOWDENDALE AVE. |
JACKSONVILLE,
FL
32216 -6042
|
|
Correspondent Contact |
JANICE G LEE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/10/2009 |
Decision Date | 03/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|