FDA 510(k) Application Details - K203264

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K203264
Device Name	Syringe, Piston
Applicant	MedOne Surgical, Inc. 670 Tallevast Road Sarasota, FL 34243 US Other 510(k) Applications for this Company
Contact	Bruce Beckstein 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	11/05/2020
Decision Date	04/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review