SLIP-ON FIXATION SPLINT (SFS)
FDA 510(k) clearance K934468 · decided 1994-08-05
Clearance details
- K-number
- K934468
- Device name
- SLIP-ON FIXATION SPLINT (SFS)
- Applicant
- Gatewood Splints
- Decision
- Substantially Equivalent
- Date received
- 1993-09-10
- Decision date
- 1994-08-05
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- EHO
- Device class
- 1
- Regulation number
- 872.3165
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dallas, TX, 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 |
|---|---|---|
| 70-X/RVG (RADIOVISIOGRAPHY) (K881133) | Trophy Radiologie | 1989-07-20 |
| DENTREK BRIDGE BARS (K883388) | Dale T. Dupuis | 1988-10-06 |
Recalls involving this device
No recalls on record reference this clearance.