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FDA 510(k) Application Details - K013711
Device Classification Name
Device, Specimen Collection
More FDA Info for this Device
510(K) Number
K013711
Device Name
Device, Specimen Collection
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA, KS 66215 US
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Contact
ROBERT E BOOTH
Other 510(k) Applications for this Contact
Regulation Number
866.2900
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Classification Product Code
LIO
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More FDA Info for this Product Code
Date Received
11/07/2001
Decision Date
11/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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