510(k) K041978

Device
REPROCESSED DIAMOND BURS
Applicant
ALLIANCE MEDICAL CORP.
510(k) number
K041978
Product code
NLN  
Decision
Substantially Equivalent (SESE)
Decision date
2004-11-23
Date received
2004-07-23
Regulation
882.4310
Classification name
Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIC VARTY
Address
10232 S. 51st St. Phoenix AZ US 85044 85044

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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