AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
FDA 510(k) clearance K924348 · decided 1992-11-23
Clearance details
- K-number
- K924348
- Device name
- AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
- Applicant
- Ad-Tech Medical Instrument Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-08-27
- Decision date
- 1992-11-23
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Racine, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.