FDA 510(k) Application Details - K955410

Device Classification Name Set, Administration, Intravascular

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510(K) Number K955410
Device Name Set, Administration, Intravascular
Applicant ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3537 US
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Contact DAVID GUZEK
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 11/27/1995
Decision Date 05/06/1996
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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