The following data is part of a premarket notification filed by Bio-medical Devices, Inc. with the FDA for Smoke-evac.
| Device ID | K981888 |
| 510k Number | K981888 |
| Device Name: | SMOKE-EVAC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-29 |
| Decision Date | 1998-10-15 |