The following data is part of a premarket notification filed by Gunter Bissinger Medizintechnik Gmbh with the FDA for Bipolar Micro-coagulation Forceps.
Device ID | K172368 |
510k Number | K172368 |
Device Name: | Bipolar Micro-Coagulation Forceps |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Gunter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 Teningen, DE |
Contact | Matthias Bissinger |
Correspondent | Matthias Bissinger Gunter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 Teningen, DE |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-07 |
Decision Date | 2018-04-05 |
Summary: | summary |