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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, transport, aerobic
510(k) Number K121039
Model 403C,404C,406C,407C
Device Name COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
Original Applicant
COPAN FLOCK TECHNOLOGIES
49 plain street
north attleboro,  MA  02760
Original Contact cynthia sinclair
Regulation Number866.2900
Classification Product Code
JTW  
Date Received04/05/2012
Decision Date 05/25/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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