FDA 510(k) Application Details - K182274

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K182274
Device Name	Syringe, Piston
Applicant	Orbit Biomedical, Inc. 300 Brookside Ave. Ambler, PA 19002 US Other 510(k) Applications for this Company
Contact	Michael Keane 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	08/22/2018
Decision Date	11/20/2018
Decision	SESK - SUBST EQUIV - KIT
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