FDA 510(k) Application Details - K031351

Device Classification Name Catheter, Peritoneal, Long-Term Indwelling

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510(K) Number K031351
Device Name Catheter, Peritoneal, Long-Term Indwelling
Applicant MEDIGROUP, INC.
505 WESTON RIDGE DR.
NAPERVILLE, IL 60563-3932 US
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Contact JOHN A NAVIS
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Regulation Number 876.5630

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Classification Product Code FJS
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Date Received 04/29/2003
Decision Date 09/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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