FDA 510(k) Application Details - K213534

Device Classification Name	More FDA Info for this Device
510(K) Number	K213534
Device Name	PHantom Trilogy
Applicant	Resurgeonz LLC 1550 Monte Carlo Court Merritt Island, FL 32952 US Other 510(k) Applications for this Company
Contact	Julie LaLonde Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2021
Decision Date	03/11/2022
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