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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 K152952
Device Name E-Cath
Applicant
Pajunk GmbH Medizintechnologie
Karl-Hall-Str 1
Geisingen,  DE 78187
Applicant Contact Christian G.H. Quass
Correspondent
Pajunk GmbH Medizintechnologie
Karl-Hall-Str 1
Geisingen,  DE 78187
Correspondent Contact Christian G.H. Quass
Regulation Number868.5120
Classification Product Code
BSO  
Date Received10/06/2015
Decision Date 07/13/2016
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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