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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 K781142
Device Name DISSCAP
Applicant
Hospal Medical Corp.
CO 
Correspondent
Hospal Medical Corp.
CO 
Regulation Number876.5820
Classification Product Code
FJI  
Date Received07/10/1978
Decision Date 09/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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