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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 K191470
Device Name C-CAT Anaesthesia Catheter kit
Cimpax ApS
Lille Pilevang 4
Slangerup,  DK 3550
Applicant Contact Patrick Busch-Madsen
Medical Device Approvals, Inc.
104 Harrison Ave.
Fairfield,  IA  52556
Correspondent Contact Kathleen Johnson
Regulation Number868.5120
Classification Product Code
Date Received06/03/2019
Decision Date 10/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No