Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Monitor, Pressure, Intracompartmental
510(k) Number K041771
Device Name TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
Applicant
Twin Star Medical, Inc.
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Twin Star Medical, Inc.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN KAHAN
Classification Product Code
LXC  
Date Received06/30/2004
Decision Date 09/14/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-