MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
FDA 510(k) clearance K021604 · decided 2002-07-29
Clearance details
- K-number
- K021604
- Device name
- MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- Applicant
- Ohio Medical Instrument Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-16
- Decision date
- 2002-07-29
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 recall (Z-1221-04) | Integra LifeSciences Corporation | 2004-07-27 |