BUDDE-HALO RETRACTOR
FDA 510(k) clearance K830332 · decided 1983-03-02
Clearance details
- K-number
- K830332
- Device name
- BUDDE-HALO RETRACTOR
- Applicant
- Ohio Medical Instrument Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-01
- Decision date
- 1983-03-02
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GZT
- Device class
- 2
- Regulation number
- 882.4800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the recall (Z-0781-03) | Ohio Medical Instrument Co Inc | 2003-04-25 |