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#
- 3003449465
- 3006946094
- 3026133744
- 3021271493
- 3019021940
- 3011219231
- 3040391047
- 3012724515
- 3014530379
- 2438600
- 3015229241
- 3013957868
- 3025349188
- 3030222358
- 3005094451
- 3006731548
- 3012796531
- 3010617503
- 3020386049
- 3007774468
- 3016244798
- 3021007058
- 3038269608
- 3022521317
- 3031182194
- 3004183518
- 3005674463
- 8040448
- 3017965799
- 3021982899
- 3005211969
- 3010889811
- 3006985123
- 3016929296
- 8043097
- 3030643434
- 3015105439
- 1000178824
- 3010364601
- 3030434441
- 3028674572
- 3004110262
- 3006942545
- 3003325113
- 2087417
- 3015112437
- 3012978407
- 3003748653
- 3027783184
- 3006210830
- 3042972929
- 3011522476
- 3027556697
- 3003047821
- 3048246487
- 3013575784
- 3008853323
- 3007842665
- 3012748937
- 3011321733
- 3004644176
- 3025367989
- 3026654653
- 3004134915
- 3018074459
- 3022808
- 3032087869
- 3013532963
- 3042284353
- 3021314602
- 3009515444
- 3008044475
- 3021376099
- 3016244741
- 3013525942
- 3011644027
- 3007801751
- 3038134332
- 3017774717
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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