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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
LFL  
Date Received11/13/2015
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
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