FDA 510(k) Application Details - K070730

Device Classification Name Catheter, Peritoneal, Long-Term Indwelling

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510(K) Number K070730
Device Name Catheter, Peritoneal, Long-Term Indwelling
Applicant MEDIGROUP, INC.
14 A STONEHILL RD.
OSWEGO, IL 60543 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 03/15/2007
Decision Date 07/03/2007
Decision SESK - SUBST EQUIV - KIT
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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