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FDA 510(k) Application Details - K030983
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K030983
Device Name
Catheter, Hemodialysis, Implanted
Applicant
DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL, MN 55112 US
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Contact
LISA STONE
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
03/28/2003
Decision Date
04/25/2003
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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