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FDA 510(k) Application Details - K082988
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
510(K) Number
K082988
Device Name
Accessories, Cleaning, For Endoscope
Applicant
MEDIVATORS REPROCESSING SYSTEMS
14605 28TH AVE., NORTH
MINNEAPOLIS, MN 55447-4822 US
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Contact
LYNN LUEDERS
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Regulation Number
876.1500
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Classification Product Code
FEB
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More FDA Info for this Product Code
Date Received
10/07/2008
Decision Date
02/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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