NIL
FDA 510(k) clearance K943613 · decided 1994-09-21
Clearance details
- K-number
- K943613
- Device name
- NIL
- Applicant
- Sing Wah International Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-27
- Decision date
- 1994-09-21
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HOI
- Device class
- 1
- Regulation number
- 886.5840
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Connaught, HK
- 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 |
|---|---|---|
| SPECTACLE FRAMES (K930435) | Venis DI A. Vendrame | 1993-09-20 |
| PYRAMID SUNGLASSES/PYRAMID READING GLASSES (K931328) | Pyramid | 1993-08-10 |
| SUNGLASSES (K910329) | Cutler & Gross Sloan Optical , Ltd. | 1991-03-12 |
| SYSTEMS OF SIGHT LOW VISION EYEWARE (K854854) | Int'L Eye Care, Inc. | 1986-02-04 |
| MAGNIFYING SPECTACLES W/PLASTIC LENSES (K844716) | Gazelle Corp. | 1985-01-03 |
| VISITEC MAGNIFYING SPECTACLES (K844038) | Visitec Co. | 1984-11-29 |
| BRILLETTE MODEL (K842835) | Cillus Company, Inc. | 1984-11-21 |
| LA VEL LATERAL VIEW EXTENSION LENS (K820732) | Peter M. Tolliver | 1982-05-03 |
| UVEX MINI-SPECS (K813548) | Bacou USA, Inc. and Uvex Safety, Inc. | 1982-03-02 |
| FENZL RETICLE (K801733) | Robert E. Fenzl, M.D. | 1980-09-16 |
Recalls involving this device
No recalls on record reference this clearance.