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FDA 510(k) Application Details - K993149
Device Classification Name
Catheter, Peritoneal, Long-Term Indwelling
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510(K) Number
K993149
Device Name
Catheter, Peritoneal, Long-Term Indwelling
Applicant
MEDIONICS INTERNATIONAL, INC.
114 ANDERSON AVE.
MARKHAM, ONTARIO L6E 1A5 CA
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Contact
MASHESH AGARWAL
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Regulation Number
876.5630
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Classification Product Code
FJS
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More FDA Info for this Product Code
Date Received
09/21/1999
Decision Date
04/28/2000
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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