The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Smokievac Electrosurgical Pencil.
| Device ID | K946104 |
| 510k Number | K946104 |
| Device Name: | SMOKIEVAC ELECTROSURGICAL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles M Hart |
| Correspondent | Charles M Hart ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1995-04-03 |