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510(k) K221005

EEA Circular Stapler with Tri-Staple Technology by Covidien — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
April 5, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

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