FDA 510(k) K240376, Electroporation System (N3000), by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

FDA 510(k) K240376, Electroporation System (N3000), by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

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Device Classification Name: Low Energy Direct Current Thermal Ablation System
510(k) Number: K240376
Device Name: Electroporation System (N3000)
Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Regulation Number: 878.44
Classification Product Code: OAB
Date Received: 2024-02-07
Decision Date: 2024-10-04
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 5,127
Fully redacted pages: 3,555
Content pages: 1,572

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