DRIVERS
FDA 510(k) clearance K781450 · decided 1978-09-27
Clearance details
- K-number
- K781450
- Device name
- DRIVERS
- Applicant
- Orthopedic Equipment Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-23
- Decision date
- 1978-09-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- GFC
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEEDLE DRIVER (K780255) | Scanlan Intl., Inc. | 1978-04-18 |
Recalls involving this device
No recalls on record reference this clearance.