510(k) K022373
- Device
- CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
- Applicant
- CANTOR & NISSEL LTD.
- 510(k) number
- K022373
- Product code
- NJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-07
- Date received
- 2002-07-22
- Regulation
- 886.5844
- Classification name
- Lens, Spectacle (prescription), For Reading Discomfort
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN DALSING
- Address
- 623 Glacier Dr. Grand Junction CO US 81503 81503
FDA Registration Numbers#
- 3030222358
- 3015531880
- 3003512352
- 3018074459
- 3014020412
- 3006946094
- 3010889811
- 3019021940
- 3002653402
- 3004489794
- 3011593607
- 3029975226
- 3008931233
- 3011219231
- 3005343641
- 3022502924
- 3028674572
- 3031590635
- 3031182560
- 3011644027
- 3017160888
- 3034629647
- 3027209650
- 3018153150
- 3042285589
- 3007817071
- 3009491490
- 3009536223
- 3030434441
- 3038281008
- 3014527836
- 3037047283
- 3042228518
- 3007886982
- 3022521317
- 3013278028
- 3044779075
- 3003047821
- 3033818635
- 3011447477
- 3027619151
- 3009305513
- 3022808
- 3017649333
- 2087417
- 3009858811
- 3007735390
- 3009090949
- 3030040625
- 3038134332
- 3003488848
- 3004620771
- 3010364601
- 3037611336
- 3005094451
- 3009744245
- 3021007058
- 1000431825
- 9680176
- 3012981754
- 3030319459
- 3004183518
- 3006540519
- 3019009783
- 3025350033
- 3016775323
- 3026035664
- 3031755043
- 3014444068
- 3004110262
- 3016170487
- 3017953755
- 3013525942
- 2438600
- 3023338978
- 3044735884
- 3031182017
- 3009330874
- 3016244798
Source Documents#
Other 510(k) Records For Product Code NJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853758 | PY-RITE | Golden Dental Products, Inc. | 1985-12-03 |
Legacy Summary#
summary
FDA Review#
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