The following data is part of a premarket notification filed by Delta Medical Electronics, Inc. with the FDA for Eliminator #bps 201 Bipolar Electro.
| Device ID | K822069 |
| 510k Number | K822069 |
| Device Name: | ELIMINATOR #BPS 201 BIPOLAR ELECTRO |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DELTA MEDICAL ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-14 |
| Decision Date | 1982-08-19 |