FDA.report

510(k) K943181

Device
DISPENSING PIN WITH ONE-WAY VALVE
Applicant
B. BRAUN OF AMERICA, INC.
510(k) number
K943181
Product code
LHI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-29
Date received
1994-07-01
Regulation
880.5440
Classification name
Set, I.v. Fluid Transfer
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
MARK S ALSBERGE
Address
824 Twelfth Ave. P.O. Box 4027 Bethlehem PA US 18018 18018

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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