FDA 510(k) Application Details - K191961

Device Classification Name	More FDA Info for this Device
510(K) Number	K191961
Device Name	OrthoGold
Applicant	Tissue Regeneration Technologies 251 Heritage Walk Woodstock, GA 30188 US Other 510(k) Applications for this Company
Contact	John Warlick Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2019
Decision Date	11/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review