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#
Legacy Summary#
summary
FDA Review#
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