FDA.report

510(k) K942848

Device
STRATO MEDICAL LIFEPORT LPS 7515
Applicant
STRATO MEDICAL CORP.
510(k) number
K942848
Product code
LJT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-01
Date received
1994-06-16
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
J. CHRISTOPHER FLAHERTY
Address
123 Brimbal Ave. P.O.B.3148 Beverly MA US 01915 01915

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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