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FDA 510(k) Application Details - K123214
Device Classification Name
Syringe, Balloon Inflation
More FDA Info for this Device
510(K) Number
K123214
Device Name
Syringe, Balloon Inflation
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact
RACHEL OWENS
Other 510(k) Applications for this Contact
Regulation Number
870.1650
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Classification Product Code
MAV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2012
Decision Date
11/13/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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