FDA 510(k) Application Details - K201945

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K201945
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Karl Storz EndoscopyAmerica Inc 2151 E Grand Ave El Segundo, CA 90245-5017 US Other 510(k) Applications for this Company
Contact	Leigh Spotten 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	07/13/2020
Decision Date	02/25/2021
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