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FDA 510(k) Application Details - K103153

Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous

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510(K) Number K103153
Device Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant ABBOTT VASCULAR-CARDIAC THERAPIES
26531 YNEZ RD.
MAILING P.O. BOX 9018
TEMECULA, CA US
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Contact SUZANNE REDMAN
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Regulation Number 000.0000

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Classification Product Code LOX
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Date Received 10/14/2010
Decision Date 12/30/2010
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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