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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 K123640
Device Name TX1 TISSUE REMOVAL SYSTEM
Applicant
Tenex Health
26902 Vista Ter.
Lake Forest,,  CA  92630
Applicant Contact DAVID SALZBERG
Correspondent
Tenex Health
26902 Vista Ter.
Lake Forest,,  CA  92630
Correspondent Contact DAVID SALZBERG
Classification Product Code
LFL  
Date Received11/26/2012
Decision Date 03/20/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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