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#
- 3007632745
- 3003668653
- 3010142106
- 3012931104
- 3007113449
- 3006984884
- 3031182560
- 3030185575
- 3013709019
- 9616939
- 3042970299
- 3013953125
- 3010675005
- 3025822227
- 3008517911
- 3038208112
- 3023876592
- 3010184873
- 3007582677
- 3033606211
- 3009831516
- 9710482
- 3009675738
- 3007864752
- 9617805
- 3010397989
- 3010595570
- 3026931988
- 9710499
- 3007735390
- 3004642455
- 3012520513
- 3038284246
- 3009961710
- 3043179616
- 3005290074
- 3003691964
- 3025112745
- 3005623341
- 3012262775
- 3013293162
- 1062202
- 3006351337
- 3008778294
- 9614827
- 3007930715
- 3027209650
- 3009206998
- 3011268445
- 3014664697
- 3023320949
- 3011321733
- 9615561
- 3026035664
- 3010168508
- 3011015142
- 1831687
- 9617617
- 3004521931
- 3004145424
- 3006034212
- 8030207
- 3007675967
- 3010952192
- 3027667933
- 3011349735
- 3003291784
- 3013023735
- 3003951061
- 3039321715
- 3016261211
- 9617808
- 3044855033
- 3009090949
- 3043648613
- 3010399203
- 2429849
- 3013767433
- 3022121580
- 3021090733
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 |