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FDA 510(k) Application Details - K111288
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K111288
Device Name
Wire, Guide, Catheter
Applicant
LAKE REGION MEDICAL
340 LAKE HAZELTINE DRIVE
CHASKA, MN 55318 US
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Contact
MATHEW PEXA
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
05/06/2011
Decision Date
08/02/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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