FDA 510(k) Application Details - K200240

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K200240
Device Name	Wrap, Sterilization
Applicant	Turbett Surgical Inc. 125 Tech Park Drive Rochester, NY 14625 US Other 510(k) Applications for this Company
Contact	Rob Turbett 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	01/31/2020
Decision Date	04/30/2020
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