FDA 510(k) Application Details - K102763

Device Classification Name Endoscopic Central Control Unit

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510(K) Number K102763
Device Name Endoscopic Central Control Unit
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 876.1500

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Classification Product Code ODA
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Date Received 09/24/2010
Decision Date 02/15/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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