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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 K872751
Device Name FLUORTRAN - C(TM)
Applicant
Para Scientific Co.
4155 Melissa Dr.
Lake Oswego,  OR  97034
Applicant Contact ERIC V CARLSON
Correspondent
Para Scientific Co.
4155 Melissa Dr.
Lake Oswego,  OR  97034
Correspondent Contact ERIC V CARLSON
Regulation Number866.2900
Classification Product Code
LIO  
Date Received07/13/1987
Decision Date 07/23/1987
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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