The following data is part of a premarket notification filed by Stackhouse, Inc. with the FDA for Stackhouse Smoke Evacuator, Models St-3000, St 3100.
| Device ID | K001082 |
| 510k Number | K001082 |
| Device Name: | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | STACKHOUSE, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Tom Gutierrez |
| Correspondent | Tom Gutierrez STACKHOUSE, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-06-15 |