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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intracompartmental
510(k) Number K131966
Device Name TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
Applicant
Twin Star Medical, Inc.
5116 Birch Rd.
Minnetonka,  MN  55345
Applicant Contact GREGORY W SACHS
Correspondent
Twin Star Medical, Inc.
5116 Birch Rd.
Minnetonka,  MN  55345
Correspondent Contact GREGORY W SACHS
Classification Product Code
LXC  
Date Received06/28/2013
Decision Date 02/07/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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