SLIP-ON FIXATION SPLINT (SFS)— 510(k) K934468
Substantially EquivalentGatewood Splints
FDA 510(k) clearance K934468 for SLIP-ON FIXATION SPLINT (SFS), Substantially Equivalent on 1994-08-05. Applicant: Gatewood Splints. Device class: 1.
Clearance details
- Applicant
- Gatewood Splints
- Product code
- Code EHO
- Device class
- Class 1
- Regulation
- 21 CFR 872.3165
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code EHO
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