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FDA 510(k) Application Details - K073266
Device Classification Name
Prosthesis, Esophageal
More FDA Info for this Device
510(K) Number
K073266
Device Name
Prosthesis, Esophageal
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact
NEIL KELLY
Other 510(k) Applications for this Contact
Regulation Number
878.3610
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Classification Product Code
ESW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2007
Decision Date
02/27/2008
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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