The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for B1 Footswitch (single Peddle), B2 (double Peddle).
| Device ID | K894602 |
| 510k Number | K894602 |
| Device Name: | B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BEACON LABORATORIES, INC. 11256 QUIVAS LOOP Westminster, CO 80234 |
| Contact | Richard P Fleenor |
| Correspondent | Richard P Fleenor BEACON LABORATORIES, INC. 11256 QUIVAS LOOP Westminster, CO 80234 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-09 |