FDA 510(k) Application Details - K170672

Device Classification Name	More FDA Info for this Device
510(K) Number	K170672
Device Name	Tamper Evident Cap For use with ENFit Syringes
Applicant	International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 US Other 510(k) Applications for this Company
Contact	Brandon Hunt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2017
Decision Date	10/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review