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FDA 510(k) Application Details - K133554
Device Classification Name
Light, Surgical, Accessories
More FDA Info for this Device
510(K) Number
K133554
Device Name
Light, Surgical, Accessories
Applicant
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
370 WABASHA STREET N
ST. PAUL, MN 55102 US
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Contact
ANDY ROLLER
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Regulation Number
878.4580
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Classification Product Code
FTA
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More FDA Info for this Product Code
Date Received
11/19/2013
Decision Date
04/08/2014
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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