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FDA 510(k) Application Details - K113487
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K113487
Device Name
Catheter, Hemodialysis, Implanted
Applicant
MEDICAL COMPONENTS INC
1499 DELP DRIVE
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
11/23/2011
Decision Date
03/09/2012
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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