FDA 510(k) Application Details - K972114

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K972114
Device Name Instrument, Ultrasonic Surgical
Applicant THE OLYMPUS OPTICAL CO.
55 NORTHERN BLVD.
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 06/05/1997
Decision Date 05/18/1998
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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