The following data is part of a premarket notification filed by Stackhouse Assoc. with the FDA for Airsafe Minivac Smoke Filtration System.
| Device ID | K912651 |
| 510k Number | K912651 |
| Device Name: | AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | STACKHOUSE ASSOC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Contact | Richard J Greff |
| Correspondent | Richard J Greff STACKHOUSE ASSOC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-07-08 |