FDA.report

510(k) K915273

Device
LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
Applicant
STRATO MEDICAL CORP.
510(k) number
K915273
Product code
LJT  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1993-07-07
Date received
1991-11-25
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
GRACE T.MCFALL
Address
Pfizer Hospital Products Group 123 Brimbal Ave. Beverly MA US 01915 01915

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
H787LPS55550Lifeport ANGIODYNAMICS, INC.2015-09-17

Legacy Summary

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FDA Review

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