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510(k) K212614

Ultrasonic Scalpel System by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2022
Date Received
August 18, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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