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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 K010366
Device Name DISPOSABLE STORAGE CAP
Applicant
MOLDED PRODUCTS INC.
P.O. BOX 15
HARLAN,  IA  51537
Applicant Contact ELISE JOHNSTON
Correspondent
MOLDED PRODUCTS INC.
P.O. BOX 15
HARLAN,  IA  51537
Correspondent Contact ELISE JOHNSTON
Regulation Number876.5820
Classification Product Code
FJI  
Date Received02/07/2001
Decision Date 11/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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