FDA 510(k) Application Details - K121039

Device Classification Name System, Transport, Aerobic

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510(K) Number K121039
Device Name System, Transport, Aerobic
Applicant COPAN FLOCK TECHNOLOGIES
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact CYNTHIA SINCLAIR
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Regulation Number 866.2900

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Classification Product Code JTW
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Date Received 04/05/2012
Decision Date 05/25/2012
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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