FDA 510(k) Application Details - K200336

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K200336
Device Name	Wrap, Sterilization
Applicant	Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 US Other 510(k) Applications for this Company
Contact	William K Andersen Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2020
Decision Date	11/12/2020
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