FDA 510(k) Application Details - K123956

Device Classification Name Light Source, Fiberoptic, Routine

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510(K) Number K123956
Device Name Light Source, Fiberoptic, Routine
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO, CA 90245-5017 US
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Contact SHIVEN GANDHI
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Regulation Number 876.1500

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Classification Product Code FCW
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Date Received 12/21/2012
Decision Date 01/25/2013
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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