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510(k) K230480

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) by Teleflex Medical — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2023
Date Received
February 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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