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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filters, Cell Collection, Tissue Processing
510(k) Number K870196
Device Name PCTE MICROPOROUS MEMBRANE FILTER
Applicant
Poretics Corp.
151 I Lindbergh Ave.
Livermore,  CA  94550
Applicant Contact HAROLD W BALLEW
Correspondent
Poretics Corp.
151 I Lindbergh Ave.
Livermore,  CA  94550
Correspondent Contact HAROLD W BALLEW
Regulation Number864.3010
Classification Product Code
KET  
Date Received01/20/1987
Decision Date 05/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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