FDA 510(k) Application Details - K000095

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K000095
Device Name Instrument, Ultrasonic Surgical
Applicant THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE, NY 11747 US
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Contact LAURA STORMS-TYLER
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 01/13/2000
Decision Date 09/26/2000
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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