FDA 510(k) Application Details - K063631

Device Classification Name Set, Administration, Intravascular

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510(K) Number K063631
Device Name Set, Administration, Intravascular
Applicant LABORATOIRES PEROUSE
Route du Manoir
IVRY LE TEMPLE 60173 FR
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Contact MARIE NOELLE EROUT
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 12/06/2006
Decision Date 10/05/2007
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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