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High Intensity Ultrasound System For Prostate Tissue Ablation

FDA product code PLP · 11 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4340
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-12-21 – 2025-11-19

Prostate tissue ablation

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