FDA 510(k) Application Details - K081073

Device Classification Name	More FDA Info for this Device
510(K) Number	K081073
Device Name	HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
Applicant	PAUSCH LLC 808 SHREWSBURY AVENUE TINTON FALLS, NJ 07724-3002 US Other 510(k) Applications for this Company
Contact	JUSTIN TICE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2008
Decision Date	12/05/2008
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