FDA 510(k) Application Details - K971609

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K971609
Device Name Instrument, Ultrasonic Surgical
Applicant SERVIZI MEDICO ESTETICI ITALINAI SRL.
15 VIA F. NEGRI
CASALE MONFERRATO (AL) IT
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Contact TONIA LATHAM
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 05/01/1997
Decision Date 08/14/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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