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FDA 510(k) Application Details - K041919
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K041919
Device Name
Set, Administration, Intravascular
Applicant
CLINICO
5 ROBERT-KOCH-STRASSE
BAD HERSFELD D-36251 DE
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Contact
REINHARD HOPF
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2004
Decision Date
10/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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