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FDA 510(k) Application Details - K980113
Device Classification Name
Stent,Metallic,Expandable,Duodenal
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510(K) Number
K980113
Device Name
Stent,Metallic,Expandable,Duodenal
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS, MN 55442 US
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Contact
Kathy Jo Fahey
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Regulation Number
878.3610
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Classification Product Code
MUM
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More FDA Info for this Product Code
Date Received
01/13/1998
Decision Date
04/03/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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