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510(k) K250779

CS-Pro MED by Curative Sound Therapeutics — Product Code PZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2025
Date Received
March 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class
Class II
Regulation Number
878.4685
Review Panel
SU
Submission Type

Treatment of diabetic foot ulcers

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