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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K181782
Device Name Medline Reinforced Epidural Catheter
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Claire Pigman
Correspondent
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Claire Pigman
Regulation Number868.5120
Classification Product Code
BSO  
Date Received07/03/2018
Decision Date 03/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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