FDA 510(k) Application Details - K022068

Device Classification Name Tubing, Dialysate

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510(K) Number K022068
Device Name Tubing, Dialysate
Applicant MOLDED PRODUCTS INC.
601 DURANT ST.
HARLAN, IA 51537 US
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Contact ELISE JOHNSTON
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Regulation Number 876.5820

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Classification Product Code FID
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Date Received 06/25/2002
Decision Date 09/23/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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