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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K981253
Device Name ULTRACON ULTRAFILTRATOR
Applicant
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact LYNN M RODARTI
Correspondent
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact LYNN M RODARTI
Regulation Number876.5820
Classification Product Code
FJI  
Date Received04/06/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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