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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 K895187
Device Name FDL, INC.'S TRANSPORT SYSTEM
Applicant
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Applicant Contact PATRICIA MANSFIELD
Correspondent
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Correspondent Contact PATRICIA MANSFIELD
Regulation Number866.2900
Classification Product Code
JTW  
Date Received08/11/1989
Decision Date 10/24/1989
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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