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FDA 510(k) Application Details - K021212
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K021212
Device Name
Catheter, Hemodialysis, Implanted
Applicant
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD, MA 01730 US
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Contact
DONALD FICKETT
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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
04/17/2002
Decision Date
05/17/2002
Decision
SESE - SUBST EQUIV
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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