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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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