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FDA 510(k) Application Details - K060897
Device Classification Name
Catheter, Peritoneal, Long-Term Indwelling
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510(K) Number
K060897
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 NEVIS
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Regulation Number
876.5630
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Classification Product Code
FJS
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Date Received
04/03/2006
Decision Date
07/18/2006
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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