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FDA 510(k) Application Details - K100395
Device Classification Name
Light, Surgical, Fiberoptic
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510(K) Number
K100395
Device Name
Light, Surgical, Fiberoptic
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
ROBERT SULLIVAN
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Regulation Number
878.4580
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Classification Product Code
FST
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Date Received
02/16/2010
Decision Date
03/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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