FDA 510(k) Application Details - K250779

Device Classification Name	More FDA Info for this Device
510(K) Number	K250779
Device Name	CS-Pro MED
Applicant	Curative Sound Therapeutics 11611 N. Meridian Street Suite 425 Carmel, IN 46032 US Other 510(k) Applications for this Company
Contact	Les Bogdanowicz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2025
Decision Date	07/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review