FDA 510(k) Application Details - K060963

Device Classification Name	Monitor, Pressure, Intracompartmental   More FDA Info for this Device
510(K) Number	K060963
Device Name	Monitor, Pressure, Intracompartmental
Applicant	TWIN STAR MEDICAL 1000 WESTGATE DRIVE, SUITE 117 ST. PAUL, MN 55114 US Other 510(k) Applications for this Company
Contact	CHET SIEVERT Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2006
Decision Date	06/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review