FDA 510(k) Application Details - K210405

Device Classification Name	More FDA Info for this Device
510(K) Number	K210405
Device Name	ProTEC-USA EZDoff Gown
Applicant	Cadillac Products, Inc. 5800 Crooks Road, Suite 100 Troy, MI 48098 US Other 510(k) Applications for this Company
Contact	Andrew Stone Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2021
Decision Date	12/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review