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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Parasite Concentration
510(k) Number K853715
Device Name PARA CON TM
Applicant
Para Scientific Co.
4155 Melissa Dr.
Lake Oswego,  OR  97034
Applicant Contact BONNY J CARLSON
Correspondent
Para Scientific Co.
4155 Melissa Dr.
Lake Oswego,  OR  97034
Correspondent Contact BONNY J CARLSON
Regulation Number866.2900
Classification Product Code
LKS  
Date Received09/04/1985
Decision Date 10/02/1985
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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