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#
- 3023266994
- 3025350033
- 3016170487
- 3011219231
- 3043141295
- 3007842665
- 3043152400
- 3033790358
- 3010617503
- 3009093215
- 3019889623
- 3014530379
- 3017296478
- 3005211969
- 3038136499
- 8040448
- 3032087869
- 3014466582
- 3014444068
- 3031182194
- 3018153150
- 3013523350
- 3009762272
- 3015004701
- 3008370976
- 3027556697
- 3030640832
- 3013532963
- 3043855055
- 9615473
- 3012724515
- 3023094364
- 3025367989
- 3014527836
- 3007421138
- 1000178824
- 3010539382
- 3014326859
- 3015167833
- 3004104721
- 3011321733
- 3017619003
- 3026877878
- 3021314602
- 3003488848
- 3029975226
- 2135464
- 3015335987
- 3021271493
- 3010364601
- 3031590635
- 3002653402
- 3042149901
- 3031599350
- 9680176
- 3021982899
- 3018064274
- 3004644176
- 3027209650
- 3008201706
- 3012748937
- 3011248235
- 3014171026
- 3025112745
- 3003082366
- 3022521317
- 3021244189
- 3007667067
- 3016929296
- 3003748653
- 3042156934
- 3005385370
- 3009858811
- 3017774717
- 3006532764
- 3018074459
- 3042285066
- 3011164728
- 3014020412
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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