Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K201593 |
Device Name |
Looking Glass 4K Integrated Visualization System |
Applicant |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Kavita Amin |
Correspondent |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Kavita Amin |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/12/2020 |
Decision Date | 07/08/2020 |
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
|