FDA 510(k) Application Details - K213632

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K213632
Device Name	Syringe, Piston
Applicant	Instylla, Inc. 201 Burlington Road, North Building Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Jennifer Greer Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2021
Decision Date	02/10/2022
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