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FDA 510(k) Application Details - K012948
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K012948
Device Name
Catheter, Hemodialysis, Implanted
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact
NICHOLAS CONDAKES
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
MSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2001
Decision Date
10/03/2001
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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