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Found 1 results

510(k) Data Aggregation

K Number

Device Name

Tulsa Pro System (Pad-105)

Manufacturer

Profound Medical, Inc.

Date Cleared

2024-05-09

(98 days)

Product Code

PLP

Regulation Number

876.4340

Why did this record match?

Applicant Name (Manufacturer) :

Profound Medical, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The TULSA-PRO ® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.

Device Description

Not Found

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