FDA 510(k) Application Details - DEN130036

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130036
Device Name	PROSTATE IMMOBILIZER RECTAL BALLOON
Applicant	RADIADYNE 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001 US Other 510(k) Applications for this Company
Contact	MARK A HELLER 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	07/15/2013
Decision Date	01/28/2014
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review