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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K951814
Device Name TRIUMPH-1 PORT
Applicant
Horizon Medical Products, Inc.
4200 Northside Pkwy. NW
Atlanta,  GA  30327
Applicant Contact RODDY J. H CLARK
Correspondent
Horizon Medical Products, Inc.
4200 Northside Pkwy. NW
Atlanta,  GA  30327
Correspondent Contact RODDY J. H CLARK
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/18/1995
Decision Date 08/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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