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FDA 510(k) Application Details - K974163
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K974163
Device Name
Set, Administration, Intravascular
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR, CA 91342 US
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Contact
DON SELVEY
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/05/1997
Decision Date
02/02/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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