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FDA 510(k) Application Details - K102527
Device Classification Name
Catheter, Urological
More FDA Info for this Device
510(K) Number
K102527
Device Name
Catheter, Urological
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact
DANIEL HOAR
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
KOD
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More FDA Info for this Product Code
Date Received
09/02/2010
Decision Date
11/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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