FDA 510(k) Application Details - K163321

Device Classification Name	Apparatus, Suction, Patient Care   More FDA Info for this Device
510(K) Number	K163321
Device Name	Apparatus, Suction, Patient Care
Applicant	ROCKET MEDICAL PLC 2-4 SEDLING RD, WEAR INDUSTRIAL ESTATE WASHINGTON NE38 9BZ GB Other 510(k) Applications for this Company
Contact	Tracy Charlton Other 510(k) Applications for this Contact
Regulation Number	870.5050   More FDA Info for this Regulation Number
Classification Product Code	DWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2016
Decision Date	08/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review