FDA 510(k) Application Details - K244026

Device Classification Name	More FDA Info for this Device
510(K) Number	K244026
Device Name	PAL 7020 Console
Applicant	MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 US Other 510(k) Applications for this Company
Contact	Glenn Gerstenfeld Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	04/25/2025
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