The following data is part of a premarket notification filed by Bergen Mfg. with the FDA for Bergen 610 Bipolar Coagulator.
| Device ID | K964736 |
| 510k Number | K964736 |
| Device Name: | BERGEN 610 BIPOLAR COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BERGEN MFG. 9345 ROOKERY RD. Newport Richey, FL 34654 |
| Contact | Roger Oosten |
| Correspondent | Roger Oosten BERGEN MFG. 9345 ROOKERY RD. Newport Richey, FL 34654 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-25 |
| Decision Date | 1997-02-27 |
| Summary: | summary |