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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 K840990
Device Name PRESERV CARY BLAIR TRANSPORT PACK
Applicant
Preventive Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Preventive Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2900
Classification Product Code
JTW  
Date Received03/07/1984
Decision Date 03/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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