Device Classification Name |
Light Source, Fiberoptic, Routine
|
510(k) Number |
K123956 |
Device Name |
POWER LED 175 |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. |
EL SEGUNDO,
CA
90245 -5017
|
|
Applicant Contact |
SHIVEN GANDHI |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. |
EL SEGUNDO,
CA
90245 -5017
|
|
Correspondent Contact |
SHIVEN GANDHI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2012 |
Decision Date | 01/25/2013 |
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
|
|
|