REPROCESSED DIAMOND BURS
FDA 510(k) clearance K041978 · decided 2004-11-23
Clearance details
- K-number
- K041978
- Device name
- REPROCESSED DIAMOND BURS
- Applicant
- Alliance Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-23
- Decision date
- 2004-11-23
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- NLN
- Device class
- 2
- Regulation number
- 882.4310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.