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#
- 3013603033
- 3008044475
- 3031182194
- 3007667067
- 3027209650
- 2135464
- 3038134332
- 3043179616
- 3043648613
- 3007421138
- 3019021940
- 3020386049
- 3043126854
- 3006540519
- 3037047283
- 3018074459
- 3006731548
- 3038310426
- 3008939601
- 3016775323
- 3038136499
- 3009536223
- 3029975226
- 3004644176
- 3010617503
- 3017953755
- 3042228518
- 3027866900
- 3016244798
- 3040391047
- 3034629647
- 3021271493
- 3042278750
- 9615473
- 3006946094
- 3006985123
- 3007289540
- 3026885374
- 3031182560
- 3014530379
- 3015248743
- 3014020412
- 3009330874
- 3011260865
- 3015004701
- 3010399203
- 3015392301
- 3038622486
- 3014171026
- 3030434441
- 3030194786
- 3015140362
- 3019009783
- 3025350033
- 2438600
- 3033790358
- 3008241164
- 8043097
- 3009761494
- 3013957868
- 3007735390
- 3012995440
- 3017296478
- 3016170487
- 3005211969
- 3026035664
- 3030640832
- 3013532963
- 3011164728
- 3021244189
- 3011307306
- 3011522476
- 3011015142
- 3015497428
- 3032027177
- 8043274
- 3017180721
- 3016929296
- 3004104721
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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