FDA 510(k) Application Details - K201031

Device Classification Name	More FDA Info for this Device
510(K) Number	K201031
Device Name	NRFit« Caps, Male and Female Neuraxial Tip Caps
Applicant	International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 US Other 510(k) Applications for this Company
Contact	David Melly Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2020
Decision Date	12/16/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review