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FDA 510(k) Application Details - K041338
Device Classification Name
Stabilizer,Heart
More FDA Info for this Device
510(K) Number
K041338
Device Name
Stabilizer,Heart
Applicant
MEDTRONIC VASCULAR
7601 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
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Contact
SCOTT CUNDY
Other 510(k) Applications for this Contact
Regulation Number
870.4500
More FDA Info for this Regulation Number
Classification Product Code
MWS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2004
Decision Date
07/19/2004
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
N
Expedited Review
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