Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K213042 |
Device Name |
Supra Non-Stick Bipolar Forceps |
Applicant |
Guenter Bissinger Medizintechnik GmbH |
Hans-Theisen-Str. 1 |
Teningen,
DE
79331
|
|
Applicant Contact |
Matthias Bissinger |
Correspondent |
Guenter Bissinger Medizintechnik GmbH |
Hans-Theisen-Str. 1 |
Teningen,
DE
79331
|
|
Correspondent Contact |
Matthias Bissinger |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/22/2021 |
Decision Date | 11/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|