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FDA 510(k) Application Details - K032430
Device Classification Name
Light Source, Fiberoptic, Routine
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510(K) Number
K032430
Device Name
Light Source, Fiberoptic, Routine
Applicant
ACUEITY, INC.
100 HAMILTON AVE., SUITE 140
PALO ALTO, CA 94301 US
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Contact
NANCY LINCE
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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
08/06/2003
Decision Date
09/05/2003
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
Y
Expedited Review
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