FDA.report

510(k) K951814

Device
TRIUMPH-1 PORT
Applicant
HORIZON MEDICAL PRODUCTS, INC.
510(k) number
K951814
Product code
LJT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-29
Date received
1995-04-18
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
RODDY J. H CLARK
Address
4200 Northside Pkwy. NW Atlanta GA US 30327 30327

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

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FDA Review

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