The following data is part of a premarket notification filed by Stackhouse, Inc. with the FDA for Freedom Aspirator, Model 6000.
| Device ID | K944116 |
| 510k Number | K944116 |
| Device Name: | FREEDOM ASPIRATOR, MODEL 6000 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | STACKHOUSE, INC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Contact | Dave Dunton |
| Correspondent | Dave Dunton STACKHOUSE, INC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1994-09-07 |