Medical Device Manufacturer · KR , Seongdong-Gu

ShenB Co., Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2020

Total

Cleared

Denied

FDA 510(k) Regulatory Record - ShenB Co., Ltd. Neurology ✕

1 devices

1-1 of 1

Regulatory consultants 510(k) submission support ecosystem

Hoy and Associates

Hoy and Associates Regulatory Consulting

Aesthetics Biomedical

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026