The following data is part of a premarket notification filed by Byron Medical with the FDA for Smokevac Electorsurgical Pencil.
| Device ID | K881460 |
| 510k Number | K881460 |
| Device Name: | SMOKEVAC ELECTORSURGICAL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron Economidy |
| Correspondent | Byron Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-07 |
| Decision Date | 1988-05-04 |