FDA 510(k) Application Details - K181424

Device Classification Name	Bag, Reservoir   More FDA Info for this Device
510(K) Number	K181424
Device Name	Bag, Reservoir
Applicant	PeDIA, LLC 2804 Albany Court Fairfax, VA 22031 US Other 510(k) Applications for this Company
Contact	Diane Miller Other 510(k) Applications for this Contact
Regulation Number	868.5320   More FDA Info for this Regulation Number
Classification Product Code	BTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2018
Decision Date	09/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review