FDA 510(k) Application Details - K123640

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K123640
Device Name Instrument, Ultrasonic Surgical
Applicant TENEX HEALTH
26902 VISTA TERRACE
LAKE FOREST, CA 92630 US
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Contact DAVID SALZBERG
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 11/26/2012
Decision Date 03/20/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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