FDA 510(k) Application Details - DEN170075

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170075
Device Name	ContainOR
Applicant	Advanced Surgical Concepts Ltd. Unit 4 Sunnybank Center, Upper Dargle Road Bray A98 E339 IE Other 510(k) Applications for this Company
Contact	Edward Hyland Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	12/19/2017
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review