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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
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