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510(k) K190663

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 by PAJUNK GmbH Medizintechnologie — Product Code BSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2019
Date Received
March 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5130
Review Panel
AN
Submission Type

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