ORMCO SYSTEM 1+ (TM)
FDA 510(k) clearance K941015 · decided 1994-03-31
Clearance details
- K-number
- K941015
- Device name
- ORMCO SYSTEM 1+ (TM)
- Applicant
- Ormco Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-03
- Decision date
- 1994-03-31
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DYH
- Device class
- 2
- Regulation number
- 872.3750
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Glendora, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.