The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for B100 Disposable Handpiece.
| Device ID | K894762 |
| 510k Number | K894762 |
| Device Name: | B100 DISPOSABLE HANDPIECE |
| Classification | Apparatus, Electrosurgical |
| 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 | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-09-15 |