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FDA 510(k) Application Details - K010993
Device Classification Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
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510(K) Number
K010993
Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact
LIAS M QUAGLIA
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Regulation Number
876.1500
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Classification Product Code
ODD
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Date Received
04/03/2001
Decision Date
04/30/2001
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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