The following data is part of a premarket notification filed by Xylog Corp. with the FDA for Meditron Bi-2000 Bipolar Generator W/irrigation.
| Device ID | K874798 |
| 510k Number | K874798 |
| Device Name: | MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-23 |
| Decision Date | 1988-02-24 |