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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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SHIVEN GANDHI
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Regulation Number
876.1500
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Classification Product Code
FCW
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More FDA Info for this Product Code
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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