Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K182696 |
Device Name |
Telepack X LED |
Applicant |
KARL STORZ Endoscopy-America, Inc |
2151 E. Grand Ave |
EI Segundo,
CA
90245
|
|
Applicant Contact |
Winkie Wong |
Correspondent |
KARL STORZ Endoscopy-America, Inc |
2151 E. Grand Ave |
EI Segundo,
CA
90245
|
|
Correspondent Contact |
Winkie Wong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/27/2018 |
Decision Date | 11/20/2018 |
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
|
|
|