FDA 510(k) Application Details - K182442

Device Classification Name	Cpb Check Valve, Retrograde Flow, In-Line   More FDA Info for this Device
510(K) Number	K182442
Device Name	Cpb Check Valve, Retrograde Flow, In-Line
Applicant	Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 US Other 510(k) Applications for this Company
Contact	Tosan Onosode Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	MJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2018
Decision Date	11/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review