Device Classification Name |
light source, fiberoptic, routine
|
510(k) Number |
K091968 |
Device Name |
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. |
EL SEGUNDO,
CA
90245
|
|
Applicant Contact |
CRYSTAL DIZOL |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. |
EL SEGUNDO,
CA
90245
|
|
Correspondent Contact |
CRYSTAL DIZOL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/01/2009 |
Decision Date | 09/14/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|