The following data is part of a premarket notification filed by Steris Corporation with the FDA for Steris Smoke Evacuation System.
| Device ID | K991167 |
| 510k Number | K991167 |
| Device Name: | STERIS SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Contact | Robert H Mccall |
| Correspondent | Robert H Mccall STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-06-03 |