FDA 510(k) Application Details - K162322

Device Classification Name Introducer, Catheter

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510(K) Number K162322
Device Name Introducer, Catheter
Applicant ACCESS SCIENTIFIC, LLC
3910 Sorrento Valley Blvd Ste 200
San Diego, CA 92121 US
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Contact WALTER CORDIGLIA
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 08/19/2016
Decision Date 11/17/2016
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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