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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name protector, transducer, dialysis
510(k) Number K925978
Device Name MPC-80 TRANSDUCER
Applicant
MOLDED PRODUCTS INC.
1606 CHATBURN AVE.
HARLAN,  IA  51537
Applicant Contact REBECCA WILL
Correspondent
MOLDED PRODUCTS INC.
1606 CHATBURN AVE.
HARLAN,  IA  51537
Correspondent Contact REBECCA WILL
Regulation Number876.5820
Classification Product Code
FIB  
Date Received11/25/1992
Decision Date 01/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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