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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 K021420
Device Name PARACON II/FECAL CONCENTRATOR II
Applicant
Para Scientific Co.
17170 Wall St.
Lake Oswego,  OR  97034
Applicant Contact ERIC CARLSON
Correspondent
Para Scientific Co.
17170 Wall St.
Lake Oswego,  OR  97034
Correspondent Contact ERIC CARLSON
Regulation Number866.2900
Classification Product Code
LKS  
Date Received05/03/2002
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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