FDA 510(k) Application Details - K091495

Device Classification Name Dislodger, Stone, Biliary

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510(K) Number K091495
Device Name Dislodger, Stone, Biliary
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 US
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Contact STACY ABBATIELLO
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Regulation Number 876.5010

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Classification Product Code LQR
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Date Received 05/20/2009
Decision Date 09/03/2009
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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