The following data is part of a premarket notification filed by Somavac Medical Solutions, Inc. with the FDA for Somavac Device.
| Device ID | K180606 |
| 510k Number | K180606 |
| Device Name: | SOMAVAC Device |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SOMAVAC Medical Solutions, Inc. 20 South Dudley Street, Suite 100 Memphis, TN 38103 |
| Contact | Esra Roan |
| Correspondent | Dawn Norman MRC-X, LLC. 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-07 |
| Decision Date | 2018-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850004219062 | K180606 | 000 |
| 00850004219058 | K180606 | 000 |
| 00850004219041 | K180606 | 000 |
| 00850004219034 | K180606 | 000 |
| 00850004219027 | K180606 | 000 |
| 00850004219096 | K180606 | 000 |
| 10850004219079 | K180606 | 000 |