FDA 510(k) Application Details - K072957

Device Classification Name Endoscope, Accessories, Narrow Band Spectrum

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510(K) Number K072957
Device Name Endoscope, Accessories, Narrow Band Spectrum
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact LAURA STORMS-TYLER
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Regulation Number 876.1500

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Classification Product Code NWB
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Date Received 10/19/2007
Decision Date 03/18/2008
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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