FDA 510(k) Application Details - K121661

Device Classification Name	More FDA Info for this Device
510(K) Number	K121661
Device Name	EZ-ASSIST-FILL
Applicant	ASSIST FILL, LLC 55 NORTHERN BLVD STE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	GRIFFIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2012
Decision Date	12/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review