FDA 510(k) Application Details - K122831

Device Classification Name Led Light Source

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510(K) Number K122831
Device Name Led Light Source
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
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 09/17/2012
Decision Date 12/14/2012
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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