FDA 510(k) Application Details - K984569

Device Classification Name Set, Administration, Intravascular

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510(K) Number K984569
Device Name Set, Administration, Intravascular
Applicant AB2 MEDICAL PRODUCTS, LLP
52 BUTTONBUSH CT.
THE WOODLANDS, TX 77380-0926 US
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Contact ARTHUR CHANDLER,III
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 12/23/1998
Decision Date 08/12/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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