FDA 510(k) Application Details - K172691

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K172691
Device Name Instrument, Ultrasonic Surgical
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho
Hachioji-shi 192-8507 JP
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Contact Toshiyuki Nakajima
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 09/06/2017
Decision Date 10/04/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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