UNIVERSAL TRIAL FRAMEE
FDA 510(k) clearance K821084 · decided 1982-06-14
Clearance details
- K-number
- K821084
- Device name
- UNIVERSAL TRIAL FRAMEE
- Applicant
- Medical Equipment Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-19
- Decision date
- 1982-06-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HPA
- Device class
- 1
- Regulation number
- 886.1415
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- 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 |
|---|---|---|
| ATL 225 MW TRAIL LENS SET (K852548) | Ascon Medical Instruments, Ltd. | 1985-07-31 |
| ATF 101 TRAIL FRAME (K852126) | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| WOODLYN LIGHTWEIGHT TRIAL FRAME (K841768) | Woodlyn, Inc. | 1984-06-01 |
| IMAGE DEFLECTOR (K833669) | Michael Onufryk | 1984-03-27 |
Recalls involving this device
No recalls on record reference this clearance.