The following data is part of a premarket notification filed by Tenex Health, Inc. with the FDA for Tenex Health Tx System.
| Device ID | K153299 |
| 510k Number | K153299 |
| Device Name: | Tenex Health TX System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | TENEX HEALTH, INC. 26902 VISTA TERRACE Lake Forest, CA 92630 |
| Contact | Gloria Pendergrass |
| Correspondent | Gloria Pendergrass TENEX HEALTH, INC. 26902 VISTA TERRACE Lake Forest, CA 92630 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857156006185 | K153299 | 000 |
| 00857156006161 | K153299 | 000 |
| 00857156006147 | K153299 | 000 |