FDA.report

510(k) K871192

Device
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
Applicant
NORFOLK MEDICAL PRODUCTS, INC.
510(k) number
K871192
Product code
LJT  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-10
Date received
1987-03-24
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MICHAEL J DALTON
Address
7307 N. Ridgeway Skokie IL US 60076 60076

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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