The following data is part of a premarket notification filed by Somavac Medical Solutions, Inc. with the FDA for Somavac 100 Sustained Vacuum System.
| Device ID | K222856 |
| 510k Number | K222856 |
| Device Name: | SOMAVAC 100 Sustained Vacuum System |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SOMAVAC Medical Solutions, Inc. 3144 Stage Post Rd Unit 101 Bartlett, TN 38133 |
| Contact | Phil Ryan |
| Correspondent | Dawn Norman MRC Global, LLC 9085 E Mineral Cir., Suite 110 Centennial, CO 80112 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-21 |
| Decision Date | 2022-10-19 |