FDA.report

510(k) K933700

Device
Dye Management System
Applicant
ABBOTT LABORATORIES
510(k) number
K933700
Product code
DQO
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-03
Date received
1993-07-29
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
FREDERICK A GUSTAFSON
Address
D-389, Ap-30 200 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers

Source Documents

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

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