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510(k) K201789

CT-STOR by Energy Delivery Solutions — Product Code NDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2021
Date Received
June 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Device Class
Class II
Regulation Number
876.5885
Review Panel
GU
Submission Type

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