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510(k) K190663

Device
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
Applicant
Pajunk GmbH Medizintechnologie
510(k) number
K190663
Product code
BSN  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-17
Date received
2019-03-15
Regulation
868.5130
Classification name
Filter, Conduction, Anesthetic
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christian G. H. Quass
Address
Karl-Hall-Str 1 Geisingen DE 78187 78187

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BSN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133004VENTED MILLEX -GV, CATHIVEX -GVMerck Millipore , Ltd.2014-03-27
K083451PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYSSmiths Medical Asd, Inc.2009-03-04
K023892MILLEX VV, GV, AND HV SYRINGE FILTER UNITSMillipore Corp.2003-01-17
K013988MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 RMillipore Corp.2002-04-04
K963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)Millipore Corp.1997-06-10
K960928SYRINGEFILTERArbor Technologies, Inc.1997-04-04
K902666ANESTHESIA CONDUCTION FILTERArbor Technologies, Inc.1991-04-23
K780519FILTER TUBEJelco Laboratories1978-05-09

Legacy Summary#

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FDA Review#

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