FDA 510(k) Application Details - K040954

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K040954
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT LABORATORIES INC
800 SAGINAW DRIVE
REDWOOD CITY, CA 94063 US
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Contact JOANNA KUSKOWSKI
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 04/13/2004
Decision Date 05/11/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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