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FDA 510(k) Application Details - K042016
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K042016
Device Name
Catheter, Hemodialysis, Implanted
Applicant
DATASCOPE CORP.
1300 MACARTHUR BLVD
MAHWAH, NJ 07430 US
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Contact
PATRICE NAPODA
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Regulation Number
876.5540
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Classification Product Code
MSD
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Date Received
07/27/2004
Decision Date
09/23/2004
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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