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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 K964144
Device Name PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
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
LIO  
Date Received10/17/1996
Decision Date 11/27/1996
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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