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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Conduction, Anesthetic
510(k) Number K190663
Device Name Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
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 Number868.5130
Classification Product Code
BSN  
Date Received03/15/2019
Decision Date 06/17/2019
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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