FDA 510(k) Application Details - K243589

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K243589
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2024
Decision Date	06/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review