FDA 510(k) Application Details - K181782

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K181782
Device Name Catheter, Conduction, Anesthetic
Applicant Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093 US
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Contact Claire Pigman
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 07/03/2018
Decision Date 03/04/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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