FDA 510(k) Application Details - K971293

Device Classification Name Set, Administration, Intravascular

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510(K) Number K971293
Device Name Set, Administration, Intravascular
Applicant ABBOTT MFG., INC.
TWO HUNDRED S. ABBOTT PRK. RD.
D 389, BLDG AP 30
ABBOTT PARK, IL 60064-3500 US
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Contact THOMAS P SAMPOGNA
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 04/07/1997
Decision Date 06/27/1997
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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