FDA.report

510(k) K964352

Device
TORQUE DEVICE
Applicant
B. BRAUN MEDICAL, INC.
510(k) number
K964352
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-28
Date received
1996-11-01
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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

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