Device Classification Name |
Confocal Optical Imaging
|
510(k) Number |
K171238 |
Device Name |
KARL STORZ ICG Imaging System |
Applicant |
Karl Storz Endoscopy- America, Inc. |
2151 E. Grand Avenue |
El Segundo,
CA
90245
|
|
Applicant Contact |
Winkie Wong |
Correspondent |
Karl Storz Endoscopy- America, Inc. |
2151 E. Grand Avenue |
El Segundo,
CA
90245
|
|
Correspondent Contact |
Winkie Wong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/27/2017 |
Decision Date | 05/25/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|