ORALIX DC— 510(k) K931001
Substantially EquivalentGendex Corp.
FDA 510(k) clearance K931001 for ORALIX DC, Substantially Equivalent on 1993-09-14. Applicant: Gendex Corp.. Device class: 2.
Clearance details
- Applicant
- Gendex Corp.
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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