FDA 510(k) Application Details - K141991

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

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510(K) Number K141991
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS COPR.
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact DAPHNEY GERMAIN-KOLAWOLE
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 07/22/2014
Decision Date 03/31/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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