FDA.report

510(k) K955179

Device
CONTRAST MEDIA SET
Applicant
B. BRAUN MEDICAL, INC.
510(k) number
K955179
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-12
Date received
1995-11-13
Regulation
892.1600
Classification name
System, X-ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
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
MARK S ALSBERGE
Address
824 Twelfth Ave. Bethlehem PA US 18018 18018

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases