RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
FDA 510(k) clearance K032054 · decided 2003-09-15
Clearance details
- K-number
- K032054
- Device name
- RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Decision
- Substantially Equivalent
- Date received
- 2003-07-02
- Decision date
- 2003-09-15
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.