The following data is part of a premarket notification filed by Guenter Bissinger Medizintechnik Gmbh with the FDA for Bitech Bipolar Scissors.
| Device ID | K042077 |
| 510k Number | K042077 |
| Device Name: | BITECH BIPOLAR SCISSORS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GUENTER BISSINGER MEDIZINTECHNIK GMBH 47 GRIESWEG Muehlheim, Baden-wuerttemberg, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean GUENTER BISSINGER MEDIZINTECHNIK GMBH 47 GRIESWEG Muehlheim, Baden-wuerttemberg, DE 78570 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-10-27 |
| Summary: | summary |