FDA 510(k) Application Details - K233222

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K233222
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Aygun Surgical Instruments Co., Inc. Organize Sanayi Bolgesi Kutlukent 55330 TR Other 510(k) Applications for this Company
Contact	Engin Basoglu 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	09/28/2023
Decision Date	12/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review