Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K182773 |
Device Name |
Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps |
Applicant |
Faulhaber Pinzetten OHG |
Daimlerstr. 1 |
Frittlingen,
DE
78665
|
|
Applicant Contact |
Dorothea Faulhaber |
Correspondent |
Faulhaber Pinzetten OHG |
Daimlerstr. 1 |
Frittlingen,
DE
78665
|
|
Correspondent Contact |
Dorothea Faulhaber |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/01/2018 |
Decision Date | 10/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|