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510(k) K242167

Sterile and Non-Sterile Ultrasonic Coupling Agent by Anhui Deepblue Medical Technology Co., Ltd. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2024
Date Received
July 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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