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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Dialysate
510(k) Number K010712
Device Name DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
Applicant
MOLDED PRODUCTS INC.
601 DURANT ST.
HARLAN,  IA  51537
Applicant Contact ELISE JOHNSTON
Correspondent
MOLDED PRODUCTS INC.
601 DURANT ST.
HARLAN,  IA  51537
Correspondent Contact ELISE JOHNSTON
Regulation Number876.5820
Classification Product Code
FID  
Date Received03/09/2001
Decision Date 09/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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