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FDA 510(k) Application Details - K022648
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K022648
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact
PAIGE SWEENEY
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
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More FDA Info for this Product Code
Date Received
08/09/2002
Decision Date
09/05/2002
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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