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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
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