Device Classification Name |
Instrument, Ultrasonic Surgical
|
510(k) Number |
K153299 |
Device Name |
Tenex Health TX System |
Applicant |
TENEX HEALTH, INC. |
26902 VISTA TERRACE |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
GLORIA PENDERGRASS |
Correspondent |
TENEX HEALTH, INC. |
26902 VISTA TERRACE |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
GLORIA PENDERGRASS |
Classification Product Code |
|
Date Received | 11/13/2015 |
Decision Date | 03/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|