FDA 510(k) Application Details - K150234

Device Classification Name	More FDA Info for this Device
510(K) Number	K150234
Device Name	Myriad Prostate Caddy┐ Immobilization Rectal Balloon Item #9901,3301
Applicant	Myriad Medical, LLC 2202 N..West Shore Blvd,Suite 200 Tampa, FL 33607 US Other 510(k) Applications for this Company
Contact	Frank Bimbo 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	02/02/2015
Decision Date	03/31/2015
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