FDA 510(k) Application Details - K213823

Device Classification Name	More FDA Info for this Device
510(K) Number	K213823
Device Name	Intera Refill Kit
Applicant	Intera Oncology, Inc. 65 Williams Street, Suite 200 Wellesley, MA 02481 US Other 510(k) Applications for this Company
Contact	Michael Gaisford Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2021
Decision Date	03/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review