The following data is part of a premarket notification filed by Bergen Mfg. with the FDA for Model 709 Bipolar Micro Coagulator.
| Device ID | K863701 |
| 510k Number | K863701 |
| Device Name: | MODEL 709 BIPOLAR MICRO COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BERGEN MFG. 5461 DECUBELLIS RD. New Port Richey, FL 33553 |
| Contact | Roger L Oosten |
| Correspondent | Roger L Oosten BERGEN MFG. 5461 DECUBELLIS RD. New Port Richey, FL 33553 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-10-14 |