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FDA 510(k) Application Details - K051280
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K051280
Device Name
Catheter, Hemodialysis, Implanted
Applicant
MEDCOMP
1499 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact
JEAN CALLOW
Other 510(k) Applications for this Contact
Regulation Number
876.5540
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Classification Product Code
MSD
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More FDA Info for this Product Code
Date Received
05/17/2005
Decision Date
11/30/2005
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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