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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 K902467
Device Name FLORA-STAT URINE TRANSPORT SYSTEM
Applicant
Wadley Biosciences Corp.
4500 Renaissance Tower
1201 Elm St.
Dallas,  TX  75270
Applicant Contact ELISABETH A EVERT
Correspondent
Wadley Biosciences Corp.
4500 Renaissance Tower
1201 Elm St.
Dallas,  TX  75270
Correspondent Contact ELISABETH A EVERT
Regulation Number866.2900
Classification Product Code
LIO  
Date Received06/04/1990
Decision Date 08/22/1990
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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