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FDA 510(k) Application Details - K003104
Device Classification Name
Device, Antimicrobial Drug Removal
More FDA Info for this Device
510(K) Number
K003104
Device Name
Device, Antimicrobial Drug Removal
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact
REBECCA A RIVAS
Other 510(k) Applications for this Contact
Regulation Number
866.2560
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Classification Product Code
LJF
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More FDA Info for this Product Code
Date Received
08/29/2000
Decision Date
10/20/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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