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510(k) K202747

Klarity Bolus by Klarity Medical & Equipment (GZ) Co., Ltd. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2021
Date Received
September 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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