FDA 510(k) Application Details - K041919

Device Classification Name Set, Administration, Intravascular

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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
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Regulation Number 880.5440

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Classification Product Code FPA
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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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