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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K073444
Device Name TRITON MEIDCAL TMED IV-SET
Applicant
TRITON MEDICAL, LLC
1705 S. CAPITAL OF TEXAS HWY
AUSTIN,  TX  78746
Applicant Contact IAN P GORDON
Correspondent
TRITON MEDICAL, LLC
1705 S. CAPITAL OF TEXAS HWY
AUSTIN,  TX  78746
Correspondent Contact IAN P GORDON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/07/2007
Decision Date 08/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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