510(k) K854854
- Device
- Systems Of Sight Low Vision Eyeware
- Applicant
- INT'L EYE CARE, INC.
- 510(k) number
- K854854
- Product code
- HOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-04
- Date received
- 1985-12-05
- Regulation
- 886.5840
- Classification name
- Spectacle, Magnifying
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES C BRADFORD
- Address
- 67 Chestnut St., Suite 425 Rochester NY US 14604 14604
FDA Registration Numbers#
- 3014161178
- 1218954
- 3023152124
- 3013023735
- 3005623341
- 3013072273
- 3006752097
- 3030444859
- 3038279070
- 3007735390
- 3014242973
- 3008044475
- 8022792
- 3038134334
- 3031860701
- 1000369642
- 1062202
- 3017905900
- 3008370976
- 3030222358
- 1000189446
- 3045891288
- 3013819854
- 3010142106
- 3042129713
- 8022554
- 3018703107
- 3004573418
- 3007502227
- 3010184873
- 3011505252
- 8030369
- 3004110262
- 3009491490
- 3009279940
- 3013510936
- 3005309207
- 9710529
- 3002880972
- 8022779
- 3034565743
- 3013293162
- 3010780273
- 3025350033
- 3041000830
- 3016792199
- 3005312815
- 3023322473
- 9616413
- 3009831516
- 9680176
- 3010229247
- 9680861
- 3014610509
- 3014168883
- 3013278028
- 3040388420
- 3011074933
- 3012362305
- 3010397989
- 3034629647
- 3004860482
- 8043173
- 3015335987
- 3031599350
- 3013556952
- 3014656175
- 3007421138
- 3008111569
- 3014444068
- 3029921664
- 3003949200
- 3008921878
- 3014817722
- 3003691964
- 8020623
- 3023094364
- 3032436225
- 3043177860
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943613 | NIL | Sing Wah International Enterprises , Ltd. | 1994-09-21 |
| K930435 | SPECTACLE FRAMES | Venis DI A. Vendrame | 1993-09-20 |
| K931328 | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | Pyramid | 1993-08-10 |
| K910329 | SUNGLASSES | Cutler & Gross Sloan Optical , Ltd. | 1991-03-12 |
| K844716 | MAGNIFYING SPECTACLES W/PLASTIC LENSES | Gazelle Corp. | 1985-01-03 |
| K844038 | VISITEC MAGNIFYING SPECTACLES | Visitec Co. | 1984-11-29 |
| K842835 | BRILLETTE MODEL | Cillus Company, Inc. | 1984-11-21 |
| K820732 | LA VEL LATERAL VIEW EXTENSION LENS | Peter M. Tolliver | 1982-05-03 |
| K813548 | UVEX MINI-SPECS | Bacou USA, Inc. and Uvex Safety, Inc. | 1982-03-02 |
| K801733 | FENZL RETICLE | Robert E. Fenzl, M.D. | 1980-09-16 |