FDA.report

510(k) K905852

Device
STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED
Applicant
STRATO MEDICAL CORP.
510(k) number
K905852
Product code
LJT  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1991-04-19
Date received
1990-12-27
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
NANCY C HALL
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 not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
H787LPS70130Lifeport NAVILYST MEDICAL, INC.2018-02-07

Legacy Summary

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FDA Review

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