510(k) K991653

Device
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
Applicant
RYMED TECHNOLOGIES, INC.
510(k) number
K991653
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-24
Date received
1999-05-13
Regulation
880.5440
Classification name
Set, Administration, 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
AL WEISENBORN
Address
19526 E. Lake Dr. Miami FL US 33015 33015

FDA Registration Numbers

Source Documents

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

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Legacy Summary

summary

FDA Review

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