WOODLYN LIGHTWEIGHT TRIAL FRAME
FDA 510(k) clearance K841768 · decided 1984-06-01
Clearance details
- K-number
- K841768
- Device name
- WOODLYN LIGHTWEIGHT TRIAL FRAME
- Applicant
- Woodlyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-27
- Decision date
- 1984-06-01
- Days to decision
- 35 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
+ Add to Predicate Builder ◉ Watch Woodlyn
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| IMAGE DEFLECTOR (K833669) | Michael Onufryk | 1984-03-27 |
| UNIVERSAL TRIAL FRAMEE (K821084) | Medical Equipment Designs, Inc. | 1982-06-14 |
Recalls involving this device
No recalls on record reference this clearance.