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FDA 510(k) Application Details - K991056
Device Classification Name
Stent, Colonic, Metalic, Expandable
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510(K) Number
K991056
Device Name
Stent, Colonic, Metalic, Expandable
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact
DANIEL J DILLON
Other 510(k) Applications for this Contact
Regulation Number
878.3610
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Classification Product Code
MQR
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More FDA Info for this Product Code
Date Received
03/30/1999
Decision Date
06/22/1999
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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