The following data is part of a premarket notification filed by Bergen Mfg. with the FDA for Bergen 710 Esu.
| Device ID | K945861 |
| 510k Number | K945861 |
| Device Name: | BERGEN 710 ESU |
| Classification | Apparatus, Electrosurgical |
| 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 | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-01 |
| Decision Date | 1995-03-01 |