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FDA 510(k) Application Details - K141781
Device Classification Name
Illuminator, Fiberoptic, Surgical Field
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510(K) Number
K141781
Device Name
Illuminator, Fiberoptic, Surgical Field
Applicant
KATALYST SURGICAL, LLC
754 Goddard ave
Chesterfield, MO 63005 US
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Contact
MERYL KOCH
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
HBI
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More FDA Info for this Product Code
Date Received
07/02/2014
Decision Date
04/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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