FDA 510(k) Application Details - K190292

Device Classification Name	Apparatus, Suction, Patient Care   More FDA Info for this Device
510(K) Number	K190292
Device Name	Apparatus, Suction, Patient Care
Applicant	Bearpac Medical 124 West Point Road Moultonborough, NH 03254 US Other 510(k) Applications for this Company
Contact	Jay Zimmerman 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	02/11/2019
Decision Date	07/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review