The following data is part of a premarket notification filed by Guenter Bissinger Medizintechnik Gmbh with the FDA for Bissinger Detachable Bipolar Coagulation-forceps.
| Device ID | K970968 |
| 510k Number | K970968 |
| Device Name: | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | GUENTER BISSINGER MEDIZINTECHNIK GMBH GOTTLIEB-DAIMLER-STR. 5 (ROHRLACHE) Teningen, DE D-79331 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf GUENTER BISSINGER MEDIZINTECHNIK GMBH GOTTLIEB-DAIMLER-STR. 5 (ROHRLACHE) Teningen, DE D-79331 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1998-05-21 |
| Summary: | summary |