FDA 510(k) Application Details - K131860

Device Classification Name Transducer, Ultrasonic

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510(K) Number K131860
Device Name Transducer, Ultrasonic
Applicant US VASCULAR, LLC
1468 HARWELL AVE
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 870.2880

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Classification Product Code JOP
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Date Received 06/24/2013
Decision Date 09/27/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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