FDA 510(k) Application Details - K240713

Device Classification Name	More FDA Info for this Device
510(K) Number	K240713
Device Name	TRAUMAGEL«
Applicant	Cresilon, Inc. 86 34th Street Suite D603/D604 Brooklyn, NY 11232 US Other 510(k) Applications for this Company
Contact	Hassaan Ahmad Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2024
Decision Date	08/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review