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#
- 3038310426
- 3015112437
- 3027866900
- 9615473
- 3013603033
- 8043274
- 3008044475
- 3032087869
- 3010364601
- 3012433574
- 3008164710
- 3007817071
- 3044465767
- 3004183518
- 3009093215
- 3042156934
- 3033818635
- 3004625743
- 3042278750
- 3031755043
- 3026885374
- 3013202270
- 3009981789
- 3015497428
- 3009761494
- 3013278028
- 3015167833
- 3008370976
- 3019009783
- 3028674572
- 3005211969
- 3021314602
- 3003325113
- 3043750614
- 3016929296
- 3026133744
- 3023266994
- 3011522476
- 3010531076
- 3043152400
- 3044779075
- 3002653402
- 3017953755
- 3007335127
- 3006210830
- 3031182017
- 3009744245
- 3007886982
- 3015172360
- 3021982899
- 3037611336
- 3011447477
- 3004134915
- 1000178824
- 3007735390
- 3008103948
- 3003488848
- 3025367989
- 3043141295
- 3027556697
- 3032027177
- 3034629647
- 9680176
- 3004833103
- 3030319459
- 3006946094
- 3043126854
- 3031590635
- 3011593607
- 3009515444
- 3009305513
- 3029723726
- 3016244741
- 3018064274
- 3043855055
- 3043648613
- 3038269608
- 3004620771
- 3016870766
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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