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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, specimen collection
510(k) Number K120846
Device Name TRANSPORT CULTURE MEDIUM DEVICE
Original Applicant
PURITAN MEDICAL PRODUCTS LLC
31 school street
p.o. box 149
guilford,  ME  04443
Original Contact mehdi karamchi
Regulation Number866.2900
Classification Product Code
LIO  
Subsequent Product Codes
JTW   JTX  
Date Received03/20/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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