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FDA 510(k) Application Details - K050232
Device Classification Name
More FDA Info for this Device
510(K) Number
K050232
Device Name
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact
PAIGE SWEENEY
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PID
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2005
Decision Date
03/11/2005
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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