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FDA 510(k) Application Details - K980438
Device Classification Name
Catheter, Hemodialysis, Non-Implanted
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510(K) Number
K980438
Device Name
Catheter, Hemodialysis, Non-Implanted
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact
JEANNE M CUSH
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Regulation Number
876.5540
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Classification Product Code
MPB
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More FDA Info for this Product Code
Date Received
02/04/1998
Decision Date
06/10/1999
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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