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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Intensity Ultrasound System For Prostate Tissue Ablation
510(k) Number K240296
Device Name Tulsa Pro System (Pad-105)
Applicant
Profound Medical, Inc.
2400 Skymark Ave. # 6
Mississauga,  CA L4W 5K5
Applicant Contact Golddy Kaur
Correspondent
Profound Medical, Inc.
2400 Skymark Ave. # 6
Mississauga,  CA L4W 5K5
Correspondent Contact Golddy Kaur
Regulation Number876.4340
Classification Product Code
PLP  
Date Received02/01/2024
Decision Date 05/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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