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FDA 510(k) Application Details - K111488
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K111488
Device Name
Wire, Guide, Catheter
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
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2011
Decision Date
06/30/2011
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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