FDA 510(k) Application Details - K180478

Device Classification Name	More FDA Info for this Device
510(K) Number	K180478
Device Name	RectalPro 75 Endorectal Balloon
Applicant	QLRAD International Ltd. Wormerweg 6 Almere 1311 XB NL Other 510(k) Applications for this Company
Contact	Arjen Winkel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2018
Decision Date	11/13/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review