FDA 510(k) Application Details - K992540

Device Classification Name Light Source, Endoscope, Xenon Arc

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510(K) Number K992540
Device Name Light Source, Endoscope, Xenon Arc
Applicant LASER OPTIK SYSTEME GMBH & CO. KG
AM SAGEWERK 11,6500 MAINZ 23
AMTSGERICHT MAINZ HRB 4527
GERMANY DE
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Contact R. HAPPERSBERGER
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Regulation Number 876.1500

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Classification Product Code GCT
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Date Received 07/29/1999
Decision Date 09/14/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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