FDA 510(k) Application Details - K170371

Device Classification Name	More FDA Info for this Device
510(K) Number	K170371
Device Name	DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
Applicant	INTERVENE Group Limited Russell Building, Brunel Science Park, Kingston Lane Uxbridge UB8 3PQ GB Other 510(k) Applications for this Company
Contact	Homer Trieu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2017
Decision Date	10/20/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review