The following data is part of a premarket notification filed by Spectro Industries, Inc. with the FDA for Surgismoke.
| Device ID | K896822 |
| 510k Number | K896822 |
| Device Name: | SURGISMOKE |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | SPECTRO INDUSTRIES, INC. 1794 MAPLE LN. Roseville, MN 55113 |
| Contact | Donald Hewitt |
| Correspondent | Donald Hewitt SPECTRO INDUSTRIES, INC. 1794 MAPLE LN. Roseville, MN 55113 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-01-11 |