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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, blood circuit, hemodialysis
510(k) Number K003712
Device Name MODIFICATION TO MALE TO MALE LUER ADAPTER
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
KOC  
Date Received12/01/2000
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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