FDA 510(k) Application Details - K160241

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K160241
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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 876.4300

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Classification Product Code KNS
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Date Received 02/01/2016
Decision Date 03/02/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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