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510(k) K223266

Hilzo Esophageal Stents by Thoracent, Inc. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2024
Date Received
October 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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