FDA 510(k) Application Details - K031305

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K031305
Device Name Instrument, Ultrasonic Surgical
Applicant OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact TINA STEFFANIE-OAK
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 04/24/2003
Decision Date 09/23/2003
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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