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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
Applicant
Cimpax ApS
Lille Pilevang 4
Slangerup,  DK 3550
Applicant Contact Patrick Busch-Madsen
Correspondent
Medical Device Approvals, Inc.
104 Harrison Ave.
Fairfield,  IA  52556
Correspondent Contact Kathleen Johnson
Regulation Number868.5120
Classification Product Code
BSO  
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
Predetermined Change
Control Plan Authorized		 No
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