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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 K172777
Device Name Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
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 Received09/14/2017
Decision Date 05/03/2018
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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