FDA 510(k) Application Details - K202325

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K202325
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Retractable Technologies, Inc. 511 Lobo Lane Little Elm, TX 75068 US Other 510(k) Applications for this Company
Contact	Becky Piroga Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2020
Decision Date	04/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review