Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K192499 |
Device Name |
Cyber Blade |
Applicant |
Sidam s.r.l |
Via Statale Sud, 169 |
Mirandola (BO),
IT
41037
|
|
Applicant Contact |
Andrea Tromba |
Correspondent |
Sidam s.r.l |
Via Statale Sud, 169 |
Mirandola (MO),
IT
41037
|
|
Correspondent Contact |
Andrea Tromba |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/11/2019 |
Decision Date | 07/31/2020 |
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
|
|
|