FDA 510(k) Application Details - K070376

Device Classification Name Light Source, Endoscope, Xenon Arc

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510(K) Number K070376
Device Name Light Source, Endoscope, Xenon Arc
Applicant CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO, FL 33773-4908 US
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Contact ELIZABETH M PAUL
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Regulation Number 876.1500

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Classification Product Code GCT
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Date Received 02/08/2007
Decision Date 08/20/2007
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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