FDA 510(k) Application Details - K130819

Device Classification Name Led Light Source

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510(K) Number K130819
Device Name Led Light Source
Applicant OLYMPUS WINTER & IBE GMBH
3500 CORPORATE PKWAY
CENTER VALLEY, PA 18034-0610 US
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Contact SHERI L MUSGNUNG
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Regulation Number 876.1500

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Classification Product Code NTN
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Date Received 03/25/2013
Decision Date 06/19/2013
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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