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FDA 510(k) Application Details - K111963
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K111963
Device Name
Catheter, Percutaneous
Applicant
BRIDGEPOINT MEDICAL
2800 CAMPUS DR STE 50
PLYMOUTH, MN 55441 US
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Contact
JILL MUNSINGER
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
07/11/2011
Decision Date
08/10/2011
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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